510(k) K021077 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
MEGA 2000 SOFT PATIENT RETURN ELECTRODE PAD
| Applicant | Megadyne Medical Products, Inc., Cincinnati OH, US |
| Decision | Substantially Equivalent, Apr 17, 2002 |
| Received | Apr 3, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K021077
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 3, 2024 | Megadyne Medical Products, Inc. Brand Name: MEGADYNE" MEGA SOFT" Reusable Patient Return Electrode
Product Name: MEGADYNE" MEGA SOFT" Reusable Patient Return Electrode
Model/Catalog Number: 0830
Software Version: N/A
Product Descrip Open, Classified |
GEI | None listed |
| Jun 30, 2023 | Megadyne Medical Products, Inc. MEGADYNE MEGA SOFT Reusable Patient Return Electrode. used during electrosurgery Open, Classified |
GEI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.