THE PORTABLE ORDERLY— 510(k) K872900

Substantially Equivalent

Edgewater Medical Equipment Systems

FDA 510(k) clearance K872900 for THE PORTABLE ORDERLY, Substantially Equivalent on 1987-08-21. Applicant: Edgewater Medical Equipment Systems.

Clearance details

Applicant
Edgewater Medical Equipment Systems
Product code
Code FWZ
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mayfield Hts., OH, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code FWZ

product code FWZ
Malfunction
932
Other
1
Total
933

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.