510(k) K810828
K810828 is an FDA 510(k) premarket notification submitted by Henry Ford Hospital for the device "NON-INVASIVE AMPLIFIER". The FDA issued a decision of Substantially Equivalent on Apr 10, 1981. The device falls under product code DRR (Amplifier And Signal Conditioner, Biopotential), a Class II device regulated under 21 CFR 870.2050.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 10, 1981
- Date Received
- Mar 24, 1981
- 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
- 510(k)