DeviceClearance

K902762

Substantially Equivalent

PM14 SOFT AIR COMPRESSOR

Applicant
Precision Medical, Inc.
Product code
BTI
Advisory panel
Anesthesiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Northampton, PA, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code BTI

product code BTI
Death
25
Malfunction
1,168
Total
1,193

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.