PHILIPS NM3 MONITOR, MODEL 7900— 510(k) K091459

Substantially Equivalent

Respironics Novametrix, LLC

FDA 510(k) clearance K091459 for PHILIPS NM3 MONITOR, MODEL 7900, Substantially Equivalent on 2009-07-28. Applicant: Respironics Novametrix, LLC.

Clearance details

Applicant: Respironics Novametrix, LLC
Product code: Code BZK
Advisory panel: Anesthesiology
Date received: 2009-05-18
Decision date: 2009-07-28
Decision: Substantially Equivalent
Clearance type: Special
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.