PHILIPS NM3 RESPIRATORY MONITOR WITH VENTASSIST— 510(k) K103578

Substantially Equivalent

Respironics Novametrix, LLC

FDA 510(k) clearance K103578 for PHILIPS NM3 RESPIRATORY MONITOR WITH VENTASSIST, Substantially Equivalent on 2011-06-02. Applicant: Respironics Novametrix, LLC.

Clearance details

Applicant: Respironics Novametrix, LLC
Product code: Code BZK
Advisory panel: Anesthesiology
Date received: 2010-12-06
Decision date: 2011-06-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wallingford, CT, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code BZK

product code BZK

Death: 2
Total: 2

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.