FLH1768M SERIES HOSPITAL BED— 510(k) K930234

Substantially Equivalent

Bertec Medical, Inc.

FDA 510(k) clearance K930234 for FLH1768M SERIES HOSPITAL BED, Substantially Equivalent on 1993-07-27. Applicant: Bertec Medical, Inc..

Clearance details

Applicant
Bertec Medical, Inc.
Product code
Code FNL
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Montreal Canada, CA
Download summary PDFView on FDA.gov ↗

Adverse events under product code FNL

product code FNL
Death
64
Injury
728
Malfunction
10,825
Other
9
Total
11,626

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.