MEGA 2000
FDA 510(k) clearance K982826 · decided 1998-11-06
Clearance details
- K-number
- K982826
- Device name
- MEGA 2000
- Applicant
- Megadyne Medical Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1998-08-11
- Decision date
- 1998-11-06
- Days to decision
- 87 days
- Clearance type
- Traditional
- Product code
- GEI
- Device class
- 2
- Regulation number
- 878.4400
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Cincinnati, OH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| MEGADYNE MEGA 2000 Patient Return Electrode. used during electrosurgery recall (Z-1994-2023) | Megadyne Medical Products, Inc. | 2023-06-30 |