510(k) K781704
K781704 is an FDA 510(k) premarket notification submitted by Tracor Instruments, Inc. for the device "STIMULATOR, TN-3001 SOMATOSENSORY". The FDA issued a decision of Substantially Equivalent on December 1, 1978. The device falls under product code GWF (Stimulator, Electrical, Evoked Response), a Class II device regulated under 21 CFR 882.1870. Tracor Instruments, Inc. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 1, 1978
- Date Received
- October 10, 1978
- 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