FINGERTIP PULSE OXIMETER— 510(k) K112804

Substantially Equivalent

Guangdong Biolight Meditech Co., Ltd.

FDA 510(k) clearance K112804 for FINGERTIP PULSE OXIMETER, Substantially Equivalent on 2012-01-27. Applicant: Guangdong Biolight Meditech Co., Ltd..

Clearance details

Applicant: Guangdong Biolight Meditech Co., Ltd.
Product code: Code DQA
Advisory panel: Cardiovascular
Date received: 2011-09-27
Decision date: 2012-01-27
Decision: Substantially Equivalent
Clearance type: Special
Location: Shanghai, 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.