510(k) K233644 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
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., Cincinnati OH, US |
| Decision | Substantially Equivalent, Jul 12, 2024 |
| Received | Nov 13, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K233644
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 26, 2023 | Megadyne Medical Products, Inc. Product Code 0846, MEGADYNE MEGA SOFT Universal Dual Patient Return Electrode, Reusable Patient Return Electrode, Mega Soft Universal Dual Cord Open, Classified |
GEI | None listed |
| Dec 26, 2023 | Megadyne Medical Products, Inc. Product Code 0847, MEGADYNE MEGA SOFT Universal Plus Patient Return Electrode, Reusable Patient Return Electrode, Mega Soft Universal Plus Open, Classified |
GEI | None listed |
| Dec 26, 2023 | Megadyne Medical Products, Inc. Product Code 0848, MEGADYNE MEGA SOFT Universal Plus Dual Patient Return Electrode, Reusable Patient Return Electrode, Mega Soft Universal Dual Plus Open, Classified |
GEI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.