DEFIB-PADS— 510(k) K855082

Substantially Equivalent

Conmedcorp

FDA 510(k) clearance K855082 for DEFIB-PADS, Substantially Equivalent on 1986-03-31. Applicant: Conmedcorp.

Clearance details

Applicant
Conmedcorp
Product code
Code LDD
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Utica, NY, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code LDD

product code LDD
Death
38
Malfunction
522
Total
560

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.