510(k) K981405
K981405 is an FDA 510(k) premarket notification submitted by Oxford Instruments, Plc. for the device "SYNERGY LT". The FDA issued a decision of Substantially Equivalent on July 16, 1998. The device falls under product code GWF (Stimulator, Electrical, Evoked Response), a Class II device regulated under 21 CFR 882.1870. Oxford Instruments, Plc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 16, 1998
- Date Received
- April 20, 1998
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stimulator, Electrical, Evoked Response
- Device Class
- Class II
- Regulation Number
- 882.1870
- Review Panel
- NE
- Submission Type