BUNN MODEL 510 MEDICATION COMPRESSOR— 510(k) K862628

Substantially Equivalent

The John Bunn Co.

FDA 510(k) clearance K862628 for BUNN MODEL 510 MEDICATION COMPRESSOR, Substantially Equivalent on 1986-08-07. Applicant: The John Bunn Co..

Clearance details

Applicant
The John Bunn Co.
Product code
Code BTI
Advisory panel
Anesthesiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Tonawanda, NY, US
Download summary PDFView 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.