Megadyne Patient Return Electrode Pad - Universal Dual (model 0846), Megadyne Patient Return Electrode Pad - Universal Plus (model 0847), Megadyne Patient Return Electrode Pad - Universal Dual Plus (model 0848)
FDA 510(k) clearance K233644 · decided 2024-07-12
Clearance details
- K-number
- K233644
- Device name
- Megadyne Patient Return Electrode Pad - Universal Dual (model 0846), Megadyne Patient Return Electrode Pad - Universal Plus (model 0847), Megadyne Patient Return Electrode Pad - Universal Dual Plus (model 0848)
- Applicant
- Megadyne Medical Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2023-11-13
- Decision date
- 2024-07-12
- Days to decision
- 242 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 |
|---|---|---|
| Product Code 0846, MEGADYNE MEGA SOFT Universal Dual Patient Return Electrode, Reusable Pa recall (Z-0598-2024) | Megadyne Medical Products, Inc. | 2023-12-26 |
| Product Code 0847, MEGADYNE MEGA SOFT Universal Plus Patient Return Electrode, Reusable Pa recall (Z-0599-2024) | Megadyne Medical Products, Inc. | 2023-12-26 |
| Product Code 0848, MEGADYNE MEGA SOFT Universal Plus Dual Patient Return Electrode, Reusab recall (Z-0600-2024) | Megadyne Medical Products, Inc. | 2023-12-26 |