The following data is part of a premarket notification filed by Quinton Electrophysiology Corp. with the FDA for Ep Amp, Model #901.
| Device ID | K925346 |
| 510k Number | K925346 |
| Device Name: | EP AMP, MODEL #901 |
| Classification | Amplifier And Signal Conditioner, Biopotential |
| Applicant | QUINTON ELECTROPHYSIOLOGY CORP. 3075 14TH AVENUE, SUITE 6 Markham, Ontario, CA L3r 2l6 |
| Contact | Harold Wodlinger |
| Correspondent | Harold Wodlinger QUINTON ELECTROPHYSIOLOGY CORP. 3075 14TH AVENUE, SUITE 6 Markham, Ontario, CA L3r 2l6 |
| Product Code | DRR |
| CFR Regulation Number | 870.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-10-22 |
| Decision Date | 1993-04-30 |