The following data is part of a premarket notification filed by Dantec Medical, Inc. with the FDA for Multi-dop S.
Device ID | K926363 |
510k Number | K926363 |
Device Name: | MULTI-DOP S |
Classification | System, Imaging, Pulsed Echo, Ultrasonic |
Applicant | DANTEC MEDICAL, INC. 1575 EYE STREET, N.W. Washington, DC 20005 |
Contact | Manthei |
Correspondent | 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 | 1992-12-21 |
Decision Date | 1995-06-19 |