The following data is part of a premarket notification filed by Quinton, Inc. with the FDA for Quinton Q-tel 418t & 419t Remote Cardiac Monitor.
| Device ID | K851302 |
| 510k Number | K851302 |
| Device Name: | QUINTON Q-TEL 418T & 419T REMOTE CARDIAC MONITOR |
| Classification | Transmitters And Receivers, Physiological Signal, Radiofrequency |
| Applicant | QUINTON, INC. 2121 TERRY AVE. Seatle, WA 98121 |
| Contact | Dan Roper |
| Correspondent | Dan Roper QUINTON, INC. 2121 TERRY AVE. Seatle, WA 98121 |
| Product Code | DRG |
| CFR Regulation Number | 870.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-04-01 |
| Decision Date | 1985-05-15 |