K252655

Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO, PO-C6AT)

510(k) number: K252655
Device name: Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO, PO-C6AT)
Applicant: Shenzhen Imdk Medical Technology Co., Ltd. CN
Product code: DQA — Oximeter
Decision date: 2026-05-11
Date received: 2025-08-22
Decision: Substantially Equivalent
Clearance type: Traditional
Advisory committee: Cardiovascular

Also available from FDA: K252655.pdf

Official FDA record: K252655

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