510(k) K913875
K913875 is an FDA 510(k) premarket notification submitted by Bard Electrophysiology for the device "BARD(R) BIOPOTENTIAL AMPLIFIER II". The FDA issued a decision of Substantially Equivalent on November 27, 1991. The device falls under product code DRQ (Amplifier And Signal Conditioner, Transducer Signal), a Class II device regulated under 21 CFR 870.2060. Bard Electrophysiology has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 27, 1991
- Date Received
- August 29, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Amplifier And Signal Conditioner, Transducer Signal
- Device Class
- Class II
- Regulation Number
- 870.2060
- Review Panel
- CV
- Submission Type