The following data is part of a premarket notification filed by Gyrus Acmi, Inc. with the FDA for Olympus Energy Power System (eps).
| Device ID | K123429 |
| 510k Number | K123429 |
| Device Name: | OLYMPUS ENERGY POWER SYSTEM (EPS) |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | GYRUS ACMI, INC. 136 TURNPIKE RD. Southborough, MA 01772 |
| Contact | Dolan Mills |
| Correspondent | Dolan Mills GYRUS ACMI, INC. 136 TURNPIKE RD. Southborough, MA 01772 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-11-07 |
| Decision Date | 2013-04-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00821925042346 | K123429 | 000 |
| 00821925027756 | K123429 | 000 |
| 00821925027770 | K123429 | 000 |
| 00821925027787 | K123429 | 000 |
| 00821925027794 | K123429 | 000 |
| 00821925027800 | K123429 | 000 |
| 00821925027886 | K123429 | 000 |
| 00821925028029 | K123429 | 000 |
| 00821925028173 | K123429 | 000 |
| 00821925027978 | K123429 | 000 |
| 00821925027817 | K123429 | 000 |
| 00821925027824 | K123429 | 000 |
| 00821925028043 | K123429 | 000 |
| 00821925028036 | K123429 | 000 |
| 00821925027831 | K123429 | 000 |
| 00821925040694 | K123429 | 000 |
| 00821925027749 | K123429 | 000 |