DQA
- 产品代码
- DQA
- 器械名称
- Oximeter
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 870.2700
- FDA 专业组
- Cardiovascular
- 上市路径
- 需提交 510(k) 上市前通告
- 该代码近三年的 510(k)
- 40 件
- 其中 Summary 已存档
- 36 份，可直接下载
- FDA 历史累计 510(k)
- 726 件（全部年份；本站只收录近三年的明细）
该代码近三年的 510(k)（40 件）
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 | 摘要 |
|---|---|---|---|---|
| K252821 | 2026-05-29 | Philips Medizin Systeme Böblingen GmbH | Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusa… | |
| K252655 | 2026-05-11 | Shenzhen Imdk Medical Technology Co., … | Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, … | |
| K253887 | 2026-05-01 | Philips Medizin Systeme | Nasal Alar SpO2 Sensor (989803205381); Nasal Alar Sp… | |
| K260931 | 2026-04-14 | Unimed Medical Supplies, Inc. | Unimed Reusable Finger Clip SpO2 Sensors (U403-49R a… | |
| K252448 | 2026-02-27 | Avita Corporation | AViTA Pulse Oximeter (SP61) | |
| K252805 | 2026-02-17 | Jiangsu Yuyue Medical Equipment & Supp… | YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, … | |
| K253109 | 2026-01-07 | Shenzhen Best Electronics Co., Ltd. | Reusable SPO2 Sensor (BSA307-47; BSA109-50; BSA109-3… | |
| K251751 | 2025-12-19 | Shenzhen Ykd Technology Co., Ltd. | Spo2 Sensor CSS032D | |
| K251696 | 2025-12-01 | Unimed Medical Supplies, Inc. | Unimed Reusable SpO2 Sensors (-48 Series and -29 Ser… | |
| K251691 | 2025-12-01 | Unimed Medical Supplies, Inc. | Unimed Reusable SpO2 Sensors (-08 Series) (U403S-08)… | |
| K251693 | 2025-11-18 | Unimed Medical Supplies, Inc. | Unimed Reusable SpO2 Sensors (-75 Series) (U410-75);… | |
| K251695 | 2025-11-18 | Unimed Medical Supplies, Inc. | Unimed Reusable SpO2 Sensors (-06 Series) (U403S-06)… | |
| K250837 | 2025-09-25 | Shanghai Berry Electronic Tech Co., Lt… | Pulse Oximeter | |
| K250931 | 2025-08-13 | Unimed Medical Supplies, Inc. | Unimed Reusable SpO2 Sensors (-117 and -121 Series) … | |
| K241086 | 2025-05-09 | Avidhrt, Inc. | Avidhrt Sense SpO2 | |
| K242876 | 2025-02-28 | Shenzhen Viatom Technology Co., Ltd. | Pulse Oximeter ( PO2, PO2A, PO2B) | |
| K233963 | 2025-02-25 | Taiwan Aulisa Medical Devices Technolo… | Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0… | |
| K243086 | 2025-02-20 | Unimed Medical Supplies, Inc. | Unimed Reusable Finger Clip SpO2 Sensors (UXXX-91 Se… | |
| K242455 | 2025-02-19 | Avita Corporation | AViTA Pulse Oximeter (SP62B) | |
| K242580 | 2025-02-06 | Unimed Medical Supplies, Inc. | Unimed Reusable Finger Clip SpO2 Sensors (U103-125);… | |
| K233956 | 2025-01-30 | Taiwan Aulisa Medical Devices Technolo… | Aulisa Infant Oximeter Module (2nd Gen.) (GA-OM0018) | |
| K243049 | 2025-01-02 | Hunan Accurate Bio-Medical Technology … | Pulse Oximeter (FS20P); Pulse Oximeter (FS20C); Puls… | |
| K241090 | 2024-11-29 | Movano Inc. Dba Movano Health | Evie Med Ring | FDA |
| K232520 | 2024-11-21 | Shenzhen Smallsignal Technology Co., L… | Fingertip Pulse Oximeter, models Alpine20, Alpine20A… | |
| K240092 | 2024-10-25 | Shenzhen Yimi Life Technology Co., Ltd… | Pulse Oximeter (YM101, YM102, YM103, YM104, YM201, Y… | |
| K234110 | 2024-10-11 | Belun Technology Company Limited | Belun Ring BLR-200 (BLR-200) | |
| K240808 | 2024-10-03 | Hunan Accurate Bio-Medical Technology … | Pulse Oximeter (WS20A) | |
| K233827 | 2024-08-28 | Oxiwear, Inc. | OxiWear | |
| K231979 | 2024-08-16 | Shenzhen Mecun Medical Supply Co., Ltd… | Mecun SpO2 sensor | FDA |
| K232989 | 2024-07-01 | Shenzhen AOJ Medical Technology Co., L… | Pulse Oximeter (AOJ-70A); Pulse Oximeter (AOJ-70B); … | |
| K232975 | 2024-06-21 | Beijing Choice Electronic Technology C… | Pulse Oximeter (MD300C228) | |
| K240305 | 2024-05-28 | Sibel Health, Inc. | ANNE Limb | |
| K223399 | 2024-05-20 | Avita Corporation | AViTA Pulse Oximeter | |
| K232495 | 2024-05-16 | Sempulse Corporation | Sempulse Halo Vital Signs Monitor | — |
| K231288 | 2024-03-04 | Vyvo Technology Corp.(Vt) | Vyvo | |
| K230277 | 2024-01-04 | Cofoe Medical Technology Co., Ltd. | Pulse Oximeter(Model OHT60,OXH78) | |
| K231531 | 2023-12-21 | Hinlab, Inc. | Pediarity | |
| K223721 | 2023-12-15 | Masimo Corporation | Masimo Stork | |
| K230587 | 2023-11-30 | Beijing Choice Electronic Technology C… | Wrist Pulse Oximeter | |
| K231243 | 2023-10-31 | Guangdong Genial Technology Co., Ltd. | Finger Clip Pulse Oximeter | — |
FDA 官方分类页： DQA
分类与上市路径以 FDA 现行公告为准。本页数据来自 openFDA（CC0 公有领域），不构成注册策略建议。