K251696

Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-48); Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-29)

510(k) number: K251696
Device name: Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-48); Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-29)
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

Also available from FDA: K251696.pdf

Official FDA record: K251696

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