K243086
- 510(k) number
- K243086
- Device name
- Unimed Reusable Finger Clip SpO2 Sensors (UXXX-91 Series) (U403-91); Unimed Reusable Finger Clip SpO2 Sensors (UXXX-91 Series) (U410-91)
- Applicant
- Unimed Medical Supplies, Inc. CN
- Product code
- DQA — Oximeter
- Decision date
- 2025-02-20
- Date received
- 2024-09-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.8 MB · U.S. public domain
Also available from FDA: K243086.pdf
Official FDA record: K243086
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.