CONMED INTEGRATED SYSTEMS NURSES ASSISTANT— 510(k) K031979

Substantially Equivalent

Conmed Integrated Systems (Cmis)

FDA 510(k) clearance K031979 for CONMED INTEGRATED SYSTEMS NURSES ASSISTANT, Substantially Equivalent on 2003-07-25. Applicant: Conmed Integrated Systems (Cmis).

Clearance details

Applicant
Conmed Integrated Systems (Cmis)
Product code
Code FSY
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Beaverton, OR, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code FSY

product code FSY
Malfunction
2,759
Other
1
Total
2,760

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.