MEGA SOFT UNIVERSAL PATIENT RETURN ELECTRODE— 510(k) K133726
Substantially EquivalentMegadyne Medical Products, Inc.
FDA 510(k) clearance K133726 for MEGA SOFT UNIVERSAL PATIENT RETURN ELECTRODE, Substantially Equivalent on 2014-01-24. Applicant: Megadyne Medical Products, Inc..
Clearance details
- Applicant
- Megadyne Medical Products, Inc.
- Product code
- Code GEI
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Draper, UT, US
Adverse events under product code GEI
product code GEI- Death
- 133
- Injury
- 7,585
- Malfunction
- 35,808
- Other
- 44
- Total
- 43,570
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.