Pulse Oximeter (UC-200, UC-201, UC-202, UC-203, UC-204, UC-100, UC-101, UC-102, UC-103, UC-104)— 510(k) K222213

Substantially Equivalent

Unimed Medical Supplies, Inc.

FDA 510(k) clearance K222213 for Pulse Oximeter (UC-200, UC-201, UC-202, UC-203, UC-204, UC-100, UC-101, UC-102, UC-103, UC-104), Substantially Equivalent on 2022-12-19. Applicant: Unimed Medical Supplies, Inc..

Clearance details

Applicant: Unimed Medical Supplies, Inc.
Product code: Code DQA
Advisory panel: Cardiovascular
Date received: 2022-07-25
Decision date: 2022-12-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code DQA

product code DQA

Death: 66
Malfunction: 2,867
Other: 1
Total: 2,934

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.