The following data is part of a premarket notification filed by Imex Medical Systems, Inc. with the FDA for Mascot Cw Doppler System.
| Device ID | K871212 |
| 510k Number | K871212 |
| Device Name: | MASCOT CW DOPPLER SYSTEM |
| Classification | Transducer, Ultrasonic |
| Applicant | IMEX MEDICAL SYSTEMS, INC. 6355 JOYCE DR. Golden, CO 80403 |
| Contact | Ed Bistrick |
| Correspondent | Ed Bistrick 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 | 1987-03-26 |
| Decision Date | 1987-08-14 |