oCare Wrist Pulse Oximeter— 510(k) K183556

Substantially Equivalent

Taiwan Biophotonic Corporation

FDA 510(k) clearance K183556 for oCare Wrist Pulse Oximeter, Substantially Equivalent on 2019-02-15. Applicant: Taiwan Biophotonic Corporation.

Clearance details

Applicant: Taiwan Biophotonic Corporation
Product code: Code DQA
Advisory panel: Cardiovascular
Date received: 2018-12-20
Decision date: 2019-02-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Zhubei, TW

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.