The following data is part of a premarket notification filed by Quinton, Inc. with the FDA for Q-smart Holter Systems.
| Device ID | K910808 |
| 510k Number | K910808 |
| Device Name: | Q-SMART HOLTER SYSTEMS |
| Classification | Detector And Alarm, Arrhythmia |
| Applicant | QUINTON, INC. 2121 TERRY AVE. Seatle, WA 98121 |
| Contact | Ron Duck |
| Correspondent | Ron Duck QUINTON, INC. 2121 TERRY AVE. Seatle, WA 98121 |
| Product Code | DSI |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-02-26 |
| Decision Date | 1991-07-17 |