The following data is part of a premarket notification filed by Medison America, Inc. with the FDA for Combison 530d With Power Doppler Mode.
| Device ID | K974813 |
| 510k Number | K974813 |
| Device Name: | COMBISON 530D WITH POWER DOPPLER MODE |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | MEDISON AMERICA, INC. 6616 OWENS DR. Pleasanton, CA 94588 |
| Contact | Bob Leiker |
| Correspondent | Bob Leiker MEDISON AMERICA, INC. 6616 OWENS DR. Pleasanton, CA 94588 |
| Product Code | IYN |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-12-23 |
| Decision Date | 1998-09-29 |
| Summary: | summary |