The following data is part of a premarket notification filed by Elekta Instruments, Inc. with the FDA for Es-100 Power System, Es-100 Series.
| Device ID | K925360 |
| 510k Number | K925360 |
| Device Name: | ES-100 POWER SYSTEM, ES-100 SERIES |
| Classification | Motor, Surgical Instrument, Ac-powered |
| Applicant | ELEKTA INSTRUMENTS, INC. 1926 NORTHLAKE PKWY. Tucker, GA 30084 |
| Contact | Marc Buntaine |
| Correspondent | Marc Buntaine ELEKTA INSTRUMENTS, INC. 1926 NORTHLAKE PKWY. Tucker, GA 30084 |
| Product Code | GEY |
| CFR Regulation Number | 878.4820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-10-22 |
| Decision Date | 1993-09-07 |