Pulse Oximeter (FRO-200, FRO-201, FRO-202, FRO-203, FRO-204, FRO-100, FRO-101, FRO-102, FRO-103, FRO-104)— 510(k) K211632

Substantially Equivalent

Shenzhen Narig Bio-Medical Technology Co., Ltd.

FDA 510(k) clearance K211632 for Pulse Oximeter (FRO-200, FRO-201, FRO-202, FRO-203, FRO-204, FRO-100, FRO-101, FRO-102, FRO-103, FRO-104), Substantially Equivalent on 2022-01-14. Applicant: Shenzhen Narig Bio-Medical Technology Co., Ltd..

Clearance details

Applicant: Shenzhen Narig Bio-Medical Technology Co., Ltd.
Product code: Code DQA
Advisory panel: Cardiovascular
Date received: 2021-05-27
Decision date: 2022-01-14
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.