The following data is part of a premarket notification filed by Oxford Instruments Medical Systems with the FDA for Synergy Iom System.
| Device ID | K984052 |
| 510k Number | K984052 |
| Device Name: | SYNERGY IOM SYSTEM |
| Classification | Electromyograph, Diagnostic |
| Applicant | OXFORD INSTRUMENTS MEDICAL SYSTEMS P.O. BOX 4341 Crofton, MD 21114 |
| Contact | E J Smith |
| Correspondent | E J Smith OXFORD INSTRUMENTS MEDICAL SYSTEMS P.O. BOX 4341 Crofton, MD 21114 |
| Product Code | IKN |
| CFR Regulation Number | 890.1375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-11-13 |
| Decision Date | 1999-05-17 |