The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Bard Biopotential Amplifier Ii.
| Device ID | K901358 |
| 510k Number | K901358 |
| Device Name: | BARD BIOPOTENTIAL AMPLIFIER II |
| Classification | Amplifier And Signal Conditioner, Transducer Signal |
| Applicant | C.R. BARD, INC. 5 FEDERAL ST. P.O. BOX 5069 Billerica, MA 01822 |
| Contact | Ernest Manfredo |
| Correspondent | Ernest Manfredo C.R. BARD, INC. 5 FEDERAL ST. P.O. BOX 5069 Billerica, MA 01822 |
| Product Code | DRQ |
| CFR Regulation Number | 870.2060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-03-23 |
| Decision Date | 1990-05-09 |