The following data is part of a premarket notification filed by Quinton, Inc. with the FDA for Q-dop.
| Device ID | K843058 |
| 510k Number | K843058 |
| Device Name: | Q-DOP |
| Classification | Transducer, Ultrasonic |
| 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 | JOP |
| CFR Regulation Number | 870.2880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-08-03 |
| Decision Date | 1985-04-10 |