The following data is part of a premarket notification filed by Quinton, Inc. with the FDA for Q-tel Rms (rehabilitation Management System), Model 000503.
| Device ID | K003576 |
| 510k Number | K003576 |
| Device Name: | Q-TEL RMS (REHABILITATION MANAGEMENT SYSTEM), MODEL 000503 |
| Classification | Detector And Alarm, Arrhythmia |
| Applicant | QUINTON, INC. 3303 MONTE VILLA PKWY. Bothell, WA 98021 -8906 |
| Contact | David Himes |
| Correspondent | David Himes QUINTON, INC. 3303 MONTE VILLA PKWY. Bothell, WA 98021 -8906 |
| Product Code | DSI |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-11-20 |
| Decision Date | 2001-01-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00812345029895 | K003576 | 000 |
| 00812345029543 | K003576 | 000 |
| 00812345029536 | K003576 | 000 |
| 00812345029529 | K003576 | 000 |
| 00812345029512 | K003576 | 000 |
| 00812345029505 | K003576 | 000 |
| 00812345029499 | K003576 | 000 |
| 00812345029482 | K003576 | 000 |
| 00817655021454 | K003576 | 000 |
| 00817655021447 | K003576 | 000 |
| 00817655021430 | K003576 | 000 |
| 00812345029550 | K003576 | 000 |
| 00812345029567 | K003576 | 000 |
| 00812345029888 | K003576 | 000 |
| 00812345029871 | K003576 | 000 |
| 00812345029642 | K003576 | 000 |
| 00812345029635 | K003576 | 000 |
| 00812345029628 | K003576 | 000 |
| 00812345029611 | K003576 | 000 |
| 00812345029604 | K003576 | 000 |
| 00812345029598 | K003576 | 000 |
| 00812345029581 | K003576 | 000 |
| 00812345029574 | K003576 | 000 |
| 00817655020105 | K003576 | 000 |