The following data is part of a premarket notification filed by Bard Electrophysiology with the FDA for Bard(r) Biopotential Amplifier Ii.
| Device ID | K913875 |
| 510k Number | K913875 |
| Device Name: | BARD(R) BIOPOTENTIAL AMPLIFIER II |
| Classification | Amplifier And Signal Conditioner, Transducer Signal |
| Applicant | BARD ELECTROPHYSIOLOGY 200 AMES POND DR. Tewksbury, MA 01876 |
| Contact | Matthew Nowland |
| Correspondent | Matthew Nowland BARD ELECTROPHYSIOLOGY 200 AMES POND DR. Tewksbury, MA 01876 |
| Product Code | DRQ |
| CFR Regulation Number | 870.2060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-08-29 |
| Decision Date | 1991-11-27 |