ENVITEC REUSABLE SPO2 SENSORS TYPE NIHON-KOHDEN— 510(k) K102270

Substantially Equivalent

Envitec-Wismar GmbH

FDA 510(k) clearance K102270 for ENVITEC REUSABLE SPO2 SENSORS TYPE NIHON-KOHDEN, Substantially Equivalent on 2011-02-22. Applicant: Envitec-Wismar GmbH.

Clearance details

Applicant: Envitec-Wismar GmbH
Product code: Code DQA
Advisory panel: Cardiovascular
Date received: 2010-08-10
Decision date: 2011-02-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Egale, WI, US

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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.