The following data is part of a premarket notification filed by Oxford Instruments, Plc. with the FDA for Synergy Lt.
| Device ID | K981405 |
| 510k Number | K981405 |
| Device Name: | SYNERGY LT |
| Classification | Stimulator, Electrical, Evoked Response |
| Applicant | OXFORD INSTRUMENTS, PLC. MANOR WAY Old Woking , Surrey, GB 9022 0ju |
| Contact | Jeff Hall |
| Correspondent | Jeff Hall OXFORD INSTRUMENTS, PLC. MANOR WAY Old Woking , Surrey, GB 9022 0ju |
| Product Code | GWF |
| CFR Regulation Number | 882.1870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-04-20 |
| Decision Date | 1998-07-16 |