MEGA 2000 SOFT DUAL CORD PATIENT RETURN ELECTRODE PAD— 510(k) K031285
Substantially EquivalentMegadyne Medical Products, Inc.
FDA 510(k) clearance K031285 for MEGA 2000 SOFT DUAL CORD PATIENT RETURN ELECTRODE PAD, Substantially Equivalent on 2003-05-19. 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
- Traditional
- Location
- Cincinnati, OH, 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.