The following data is part of a premarket notification filed by Dantec Medical, Inc. with the FDA for Multi-dop X.
| Device ID | K931801 |
| 510k Number | K931801 |
| Device Name: | MULTI-DOP X |
| Classification | System, Imaging, Pulsed Echo, 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 | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-01-28 |
| Decision Date | 1995-06-14 |