K252821
- 510(k) number
- K252821
- Device name
- Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m) (M1196T)
- Applicant
- Philips Medizin Systeme Böblingen GmbH DE
- Product code
- DQA — Oximeter
- Decision date
- 2026-05-29
- Date received
- 2025-09-04
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K252821.pdf
Official FDA record: K252821
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.