510(k) K854396
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 8, 1986
- Date Received
- October 31, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tester, Electrode/Lead, Electroencephalograph
- Device Class
- Class I
- Regulation Number
- 882.1410
- Review Panel
- NE
- Submission Type