BIBAG— 510(k) K791198

Substantially Equivalent

Ab Medett Produkter

FDA 510(k) clearance K791198 for BIBAG, Substantially Equivalent on 1979-07-30. Applicant: Ab Medett Produkter.

Clearance details

Applicant
Ab Medett Produkter
Product code
Code KNX
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Walker, MI, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code KNX

product code KNX
Malfunction
1,064
Total
1,064

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.