The following data is part of a premarket notification filed by Dantec Medical, Inc. with the FDA for Multi-dop L.
| Device ID | K930458 |
| 510k Number | K930458 |
| Device Name: | MULTI-DOP L |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | DANTEC MEDICAL, INC. 1575 EYE STREET, N.W. Washington, DC 20005 |
| Contact | Richard D Manthei |
| Correspondent | Richard D Manthei DANTEC MEDICAL, INC. 1575 EYE STREET, N.W. Washington, DC 20005 |
| Product Code | IYN |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-01-28 |
| Decision Date | 1995-02-03 |