APEXNRG RIDER— 510(k) K101177

Substantially Equivalent

Medicnrg , Ltd.

FDA 510(k) clearance K101177 for APEXNRG RIDER, Substantially Equivalent on 2010-10-08. Applicant: Medicnrg , Ltd..

Clearance details

Applicant
Medicnrg , Ltd.
Product code
Code LQY
Advisory panel
Unknown
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Somerset, MA, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code LQY

product code LQY
Malfunction
504
Total
504

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.