K251691

Unimed Reusable SpO2 Sensors (-08 Series) (U403S-08); Unimed Reusable SpO2 Sensors (-08 Series) (U203S-08); Unimed Reusable SpO2 Sensors (-08 Series) (U103S-08); Unimed Reusable SpO2 Sensors (-08 Series) (U103-08)

510(k) number: K251691
Device name: Unimed Reusable SpO2 Sensors (-08 Series) (U403S-08); Unimed Reusable SpO2 Sensors (-08 Series) (U203S-08); Unimed Reusable SpO2 Sensors (-08 Series) (U103S-08); Unimed Reusable SpO2 Sensors (-08 Series) (U103-08)
Applicant: Unimed Medical Supplies, Inc. CN
Product code: DQA — Oximeter
Decision date: 2025-12-01
Date received: 2025-06-02
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: K251691.pdf

Official FDA record: K251691

Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.