KNG
- Product code
- KNG
- Device name
- Monitor, Ultrasonic, Fetal
- Device class
- Class 2
- 21 CFR
- 21 CFR 884.2660
- Medical specialty
- Obstetrics/Gynecology
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 4
- Summaries archived here
- 3 (direct download)
- 510(k) clearances (all years, FDA)
- 60 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (4)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K252669 | 2026-01-08 | Zhongshan Xiaolan Town Senlan Electron… | Fetal Doppler U8-25, U9-25 | |
| K242846 | 2025-06-26 | Shenzhen Bestman Instrument Co., Ltd. | Doppler FHR Detector (BF-500D+, BF-560) | |
| K233823 | 2024-06-28 | Shenzhen Jamr Technology Co., Ltd. | Ultrasonic Fetal Doppler | — |
| K232893 | 2024-06-14 | Contec Medical Systems Co.,Ltd | Pocket Fetal Doppler (CONTEC 10D), Pocket Fetal Dopp… |
Official FDA classification page: KNG
Classification and pathway per current FDA publications. Data from openFDA (CC0).