Fingertip Pulse Oximeters M70, M70A, M70B, M70C, M70D— 510(k) K151287

Substantially Equivalent

Guangdong Biolight Meditech Co., Ltd.

FDA 510(k) clearance K151287 for Fingertip Pulse Oximeters M70, M70A, M70B, M70C, M70D, Substantially Equivalent on 2016-01-06. Applicant: Guangdong Biolight Meditech Co., Ltd..

Clearance details

Applicant: Guangdong Biolight Meditech Co., Ltd.
Product code: Code DQA
Advisory panel: Cardiovascular
Date received: 2015-05-14
Decision date: 2016-01-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Zhuhai,, 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.