510(k) K860903
K860903 is an FDA 510(k) premarket notification submitted by Tracor Northern, Inc. for the device "TM-3600 A NEURODIAGNOSTIC SYSTEM". The FDA issued a decision of Substantially Equivalent on Jun 5, 1986. The device falls under product code GWF (Stimulator, Electrical, Evoked Response), a Class II device regulated under 21 CFR 882.1870. Tracor Northern, Inc. has 9 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 5, 1986
- Date Received
- Mar 10, 1986
- 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
- 510(k)