Pulse Oximeter— 510(k) K172616

Substantially Equivalent

Beijing Safe Heart Technology , Ltd.

FDA 510(k) clearance K172616 for Pulse Oximeter, Substantially Equivalent on 2018-07-27. Applicant: Beijing Safe Heart Technology , Ltd..

Clearance details

Applicant: Beijing Safe Heart Technology , Ltd.
Product code: Code DQA
Advisory panel: Cardiovascular
Date received: 2017-08-31
Decision date: 2018-07-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beijing Economic-Technological Developme, 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.