CONVENIENCE TRAY— 510(k) K770370

Substantially Equivalent

Johannah Medical Services, Inc.

FDA 510(k) clearance K770370 for CONVENIENCE TRAY, Substantially Equivalent on 1977-03-16. Applicant: Johannah Medical Services, Inc..

Clearance details

Applicant
Johannah Medical Services, Inc.
Product code
Code FMI
Advisory panel
General Hospital
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 FMI

product code FMI
Death
28
Injury
1,517
Malfunction
23,981
Other
18
Total
25,544

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.