Leadtek Fingertip Pulse Oximeter (Wireless), Leadtek Fingertip Pulse Oximeter (Wireless)— 510(k) K210032

Substantially Equivalent

Leadtek Research, Inc.

FDA 510(k) clearance K210032 for Leadtek Fingertip Pulse Oximeter (Wireless), Leadtek Fingertip Pulse Oximeter (Wireless), Substantially Equivalent on 2021-09-01. Applicant: Leadtek Research, Inc..

Clearance details

Applicant: Leadtek Research, Inc.
Product code: Code DQA
Advisory panel: Cardiovascular
Date received: 2021-01-05
Decision date: 2021-09-01
Decision: Substantially Equivalent
Clearance type: Special
Location: New Taipei City, 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.