510(k) K874441
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 19, 1988
- Date Received
- October 28, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Amplifier And Signal Conditioner, Biopotential
- Device Class
- Class II
- Regulation Number
- 870.2050
- Review Panel
- CV
- Submission Type