510(k) K901358
K901358 is an FDA 510(k) premarket notification submitted by C.R. Bard, Inc. for the device "BARD BIOPOTENTIAL AMPLIFIER II". The FDA issued a decision of Substantially Equivalent on May 9, 1990. The device falls under product code DRQ (Amplifier And Signal Conditioner, Transducer Signal), a Class II device regulated under 21 CFR 870.2060. C.R. Bard, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 9, 1990
- Date Received
- March 23, 1990
- 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