ENVITEC REUSABLE MULTI-SITE Y SPO2 SENSORS— 510(k) K043463

Substantially Equivalent

Envitec-Wismar GmbH

FDA 510(k) clearance K043463 for ENVITEC REUSABLE MULTI-SITE Y SPO2 SENSORS, Substantially Equivalent on 2005-02-11. Applicant: Envitec-Wismar GmbH.

Clearance details

Applicant: Envitec-Wismar GmbH
Product code: Code DQA
Advisory panel: Cardiovascular
Date received: 2004-12-15
Decision date: 2005-02-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Egale, WI, US

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.