POWERNEB— 510(k) K051964

Substantially Equivalent

Comedica , Inc.

FDA 510(k) clearance K051964 for POWERNEB, Substantially Equivalent on 2005-12-01. Applicant: Comedica , Inc..

Clearance details

Applicant: Comedica , Inc.
Product code: Code NHJ
Advisory panel: Anesthesiology
Date received: 2005-07-20
Decision date: 2005-12-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Plano, TX, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code NHJ

product code NHJ

Death: 7
Total: 7

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.