The following data is part of a premarket notification filed by Quinton, Inc. with the FDA for Synergy Cardiology Information System (00431).
| Device ID | K964784 |
| 510k Number | K964784 |
| Device Name: | SYNERGY CARDIOLOGY INFORMATION SYSTEM (00431) |
| Classification | Electrocardiograph |
| Applicant | QUINTON, INC. 3303 MONTE VILLA PKWY. Bothell, WA 98021 -8906 |
| Contact | Matthew Hedlund |
| Correspondent | Matthew Hedlund QUINTON, INC. 3303 MONTE VILLA PKWY. Bothell, WA 98021 -8906 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-11-27 |
| Decision Date | 1997-08-13 |
| Summary: | summary |