DeviceClearance

K210844

Substantially Equivalent

DreamWear Silicone Pillows Mask

Applicant
Respironics, Inc.
Product code
BZD
Advisory panel
Anesthesiology
Date received
Decision date
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, through . 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.