The following data is part of a premarket notification filed by Quinton Cardiology, Inc. with the FDA for Quinton Q-te; Rms.
| Device ID | K041607 |
| 510k Number | K041607 |
| Device Name: | QUINTON Q-TE; RMS |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | QUINTON CARDIOLOGY, INC. 3303 MONTE VILLA PKWY. Bothell, WA 98021 |
| Contact | Karen Browne |
| Correspondent | Karen Browne QUINTON CARDIOLOGY, INC. 3303 MONTE VILLA PKWY. Bothell, WA 98021 |
| Product Code | MHX |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-06-15 |
| Decision Date | 2004-07-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00732094285987 | K041607 | 000 |
| 00732094307368 | K041607 | 000 |
| 00732094307375 | K041607 | 000 |
| 00732094325966 | K041607 | 000 |
| 00732094325973 | K041607 | 000 |
| 00817655023106 | K041607 | 000 |
| 00732094258998 | K041607 | 000 |
| 00732094272154 | K041607 | 000 |
| 00732094272161 | K041607 | 000 |
| 00732094272178 | K041607 | 000 |
| 00732094272222 | K041607 | 000 |
| 00732094272239 | K041607 | 000 |
| 00732094272673 | K041607 | 000 |
| 00732094307351 | K041607 | 000 |