DeviceClearance

K050414

Substantially Equivalent

PLIX

Applicant
Respironics, Inc.
Product code
BYJ
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 BYJ

product code BYJ
Death
16
Total
16

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.