APEXNRG-BLUE ELECTRONIC APEX LOCATOR— 510(k) K071133
Substantially EquivalentMedicnrg , Ltd.
FDA 510(k) clearance K071133 for APEXNRG-BLUE ELECTRONIC APEX LOCATOR, Substantially Equivalent on 2007-09-21. 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
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.