The following data is part of a premarket notification filed by Dantec Medical, Inc. with the FDA for Dantec Ud 5500 Mk2.
| Device ID | K913169 |
| 510k Number | K913169 |
| Device Name: | DANTEC UD 5500 MK2 |
| Classification | Cystometric Gas (carbon-dioxide) On Hydraulic Device |
| 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 | FAP |
| CFR Regulation Number | 876.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-07-17 |
| Decision Date | 1992-01-23 |