510(k) K842964
K842964 is an FDA 510(k) premarket notification submitted by Tracor Northern, Inc. for the device "PHOTIC STIMULATOR TM-3030-70". The FDA issued a decision of Substantially Equivalent on Dec 28, 1984. 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
- Dec 28, 1984
- Date Received
- Jul 27, 1984
- 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)