510(k) K080741 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
MEGA SOFT REUSABLE PATIENT RETURN ELECTRODE
| Applicant | Megadyne Medical Products, Inc., Draper UT, US |
| Decision | Substantially Equivalent, Dec 16, 2008 |
| Received | Mar 17, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080741
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 3, 2024 | Megadyne Medical Products, Inc. Brand Name: MEGADYNE" MEGA 2000" Patient Return Electrode
Product Name: MEGADYNE" MEGA 2000" Patient Return Electrode
Model/Catalog Number: 0800
Software Version: N/A
Product Description: Reusable Pat Open, Classified |
GEI | None listed |
| Jun 6, 2024 | Megadyne Medical Products, Inc. MEGADYNE MEGA SOFT Pediatric Patient Return Electrode. Reusable Patient Return Electrode for patients weighing (0.8lb-50lb), (350g-22.7Kg), 66cm Long x 30.5cm Wide x 1.25cm. Electrosurgical use. Open, Classified |
GEI | None listed |
| Jun 30, 2023 | Megadyne Medical Products, Inc. MEGADYNE MEGA SOFT Pediatric 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.