The following data is part of a premarket notification filed by Quinton Electrophysiology Corp. with the FDA for Epxpress System (timberwolf Revision) /000391.
| Device ID | K971570 |
| 510k Number | K971570 |
| Device Name: | EPXPRESS SYSTEM (TIMBERWOLF REVISION) /000391 |
| Classification | Amplifier And Signal Conditioner, Biopotential |
| Applicant | QUINTON ELECTROPHYSIOLOGY CORP. 3303 MONTE VILLA PKWY. Bothell, WA 98021 |
| Contact | Matthew Hedlund |
| Correspondent | Matthew Hedlund QUINTON ELECTROPHYSIOLOGY CORP. 3303 MONTE VILLA PKWY. Bothell, WA 98021 |
| Product Code | DRR |
| CFR Regulation Number | 870.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-04-29 |
| Decision Date | 1997-12-29 |
| Summary: | summary |