K232520
- 510(k) number
- K232520
- Device name
- Fingertip Pulse Oximeter, models Alpine20, Alpine20A, Alpine20H, Alpine20HA, Alpine20B, Alpine20BA, Alpine20BH, Alpine20BHA, Alpine30, Alpine30A, Alpine30H, Alpine30HA, Alpine30B, Alpine30BA, Alpine30BH, Alpine30BHA, Alpine20L, Alpine20LB, Alpine20LH, Alpine20LBH, Alpine30L, Alpine30LB, Alpine30LH, Alpine30LBH
- Applicant
- Shenzhen Smallsignal Technology Co., Ltd. CN
- Product code
- DQA — Oximeter
- Decision date
- 2024-11-21
- Date received
- 2023-08-18
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K232520.pdf
Official FDA record: K232520
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.