ANESTHESIA MACHINE— 510(k) K771057

Substantially Equivalent

Foregger

FDA 510(k) clearance K771057 for ANESTHESIA MACHINE, Substantially Equivalent on 1977-07-05. Applicant: Foregger.

Clearance details

Applicant
Foregger
Product code
Code BSZ
Advisory panel
Anesthesiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mchenry, IL, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code BSZ

product code BSZ
Death
23
Injury
298
Malfunction
32,987
Total
33,308

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.