REVOLUTIONFULL FACE MASK— 510(k) K082866

Substantially Equivalent

Respironics Inc., Sleep & Home Respiratory Group

FDA 510(k) clearance K082866 for REVOLUTIONFULL FACE MASK, Substantially Equivalent on 2009-01-30. Applicant: Respironics Inc., Sleep & Home Respiratory Group.

Clearance details

Applicant: Respironics Inc., Sleep & Home Respiratory Group
Product code: Code BZD
Advisory panel: Anesthesiology
Date received: 2008-09-29
Decision date: 2009-01-30
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.