510(k) K832084
K832084 is an FDA 510(k) premarket notification submitted by Tracor Northern, Inc. for the device "EVOKED 3500 POTENTIAL SYSTEM". The FDA issued a decision of Substantially Equivalent on Aug 16, 1983. The device falls under product code GWE (Stimulator, Photic, Evoked Response), a Class II device regulated under 21 CFR 882.1890. Tracor Northern, Inc. has 9 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 16, 1983
- Date Received
- Jun 28, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Stimulator, Photic, Evoked Response
- Device Class
- Class II
- Regulation Number
- 882.1890
- Review Panel
- NE
- Submission Type
- 510(k)