The following data is part of a premarket notification filed by Quinton, Inc. with the FDA for Quinton Q-stress, Model 000483.
| Device ID | K001492 |
| 510k Number | K001492 |
| Device Name: | QUINTON Q-STRESS, MODEL 000483 |
| Classification | Electrocardiograph |
| 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 | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-05-12 |
| Decision Date | 2000-08-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00812345027723 | K001492 | 000 |
| 00812345027587 | K001492 | 000 |
| 00812345027570 | K001492 | 000 |
| 00812345027563 | K001492 | 000 |
| 00817655023182 | K001492 | 000 |
| 00817655021935 | K001492 | 000 |
| 00817655021881 | K001492 | 000 |
| 00817655021355 | K001492 | 000 |
| 00817655021331 | K001492 | 000 |
| 00817655021119 | K001492 | 000 |
| 00817655020754 | K001492 | 000 |
| 00812345027594 | K001492 | 000 |
| 00812345027600 | K001492 | 000 |
| 00812345027617 | K001492 | 000 |
| 00812345027716 | K001492 | 000 |
| 00812345027709 | K001492 | 000 |
| 00812345027693 | K001492 | 000 |
| 00812345027686 | K001492 | 000 |
| 00812345027679 | K001492 | 000 |
| 00812345027662 | K001492 | 000 |
| 00812345027655 | K001492 | 000 |
| 00812345027648 | K001492 | 000 |
| 00812345027631 | K001492 | 000 |
| 00812345027624 | K001492 | 000 |
| 00817655020075 | K001492 | 000 |