510(k) K883869
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 30, 1988
- Date Received
- September 13, 1988
- 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