K242580

Unimed Reusable Finger Clip SpO2 Sensors (U103-125); Unimed Reusable Finger Clip SpO2 Sensors (U403-254); Unimed Reusable Finger Clip SpO2 Sensors (U103-254); Unimed Reusable Finger Clip SpO2 Sensors (U403-125)

510(k) number: K242580
Device name: Unimed Reusable Finger Clip SpO2 Sensors (U103-125); Unimed Reusable Finger Clip SpO2 Sensors (U403-254); Unimed Reusable Finger Clip SpO2 Sensors (U103-254); Unimed Reusable Finger Clip SpO2 Sensors (U403-125)
Applicant: Unimed Medical Supplies, Inc. CN
Product code: DQA — Oximeter
Decision date: 2025-02-06
Date received: 2024-08-30
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: K242580.pdf

Official FDA record: K242580

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