DeviceClearance

K102985

Substantially Equivalent

V60 VENTILATOR WITH PPV AND AUTO-TRAK+ SOFTWARE OPTIONS

Applicant
Respironics, Inc.
Product code
MNT
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 MNT

product code MNT
Death
118
Injury
324
Malfunction
25,451
Other
2
Total
25,895

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.