The following data is part of a premarket notification filed by Imex Medical Systems, Inc. with the FDA for Doplette 10.
| Device ID | K851269 |
| 510k Number | K851269 |
| Device Name: | DOPLETTE 10 |
| Classification | Transducer, Ultrasonic |
| Applicant | IMEX MEDICAL SYSTEMS, INC. 6355 JOYCE DR. Golden, CO 80403 |
| Contact | Gary Steffenson |
| Correspondent | Gary Steffenson IMEX MEDICAL SYSTEMS, INC. 6355 JOYCE DR. Golden, CO 80403 |
| Product Code | JOP |
| CFR Regulation Number | 870.2880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-01-23 |
| Decision Date | 1985-07-29 |