REVOLUTION FULLFACE MASK— 510(k) K140580

Substantially Equivalent

Respironics Inc. (Dba Philips Respironics)

FDA 510(k) clearance K140580 for REVOLUTION FULLFACE MASK, Substantially Equivalent on 2015-01-16. Applicant: Respironics Inc. (Dba Philips Respironics).

Clearance details

Applicant: Respironics Inc. (Dba Philips Respironics)
Product code: Code BZD
Advisory panel: Anesthesiology
Date received: 2014-03-06
Decision date: 2015-01-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Murrysville, PA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code BZD

product code BZD

Death: 4,440
Injury: 53,099
Malfunction: 213,222
Other: 17
Total: 270,778

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.