The following data is part of a premarket notification filed by Fisher Imaging Corp. with the FDA for Bers-400a Electrophysiological Amplifiers & Input.
| Device ID | K853652 |
| 510k Number | K853652 |
| Device Name: | BERS-400A ELECTROPHYSIOLOGICAL AMPLIFIERS & INPUT |
| Classification | Amplifier And Signal Conditioner, Biopotential |
| Applicant | FISHER IMAGING CORP. 125 SOUTH FIFTH ST. P.O. BOX 0342 Reading, PA 19603 |
| Contact | Murray Bloom |
| Correspondent | Murray Bloom FISHER IMAGING CORP. 125 SOUTH FIFTH ST. P.O. BOX 0342 Reading, PA 19603 |
| Product Code | DRR |
| CFR Regulation Number | 870.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-09-03 |
| Decision Date | 1986-01-16 |