The following data is part of a premarket notification filed by Dantec Medical, Inc. with the FDA for Etude, Urodynamic Investigation System.
| Device ID | K901494 |
| 510k Number | K901494 |
| Device Name: | ETUDE, URODYNAMIC INVESTIGATION SYSTEM |
| 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 | 1990-03-29 |
| Decision Date | 1990-10-26 |