The following data is part of a premarket notification filed by Dantec Medical, Inc. with the FDA for Dantec Da Capo.
| Device ID | K953999 |
| 510k Number | K953999 |
| Device Name: | DANTEC DA CAPO |
| Classification | Uroflowmeter |
| Applicant | DANTEC MEDICAL, INC. 3 PEARL CT. Allendale, NJ 07401 |
| Contact | Alan Schaefer |
| Correspondent | Alan Schaefer DANTEC MEDICAL, INC. 3 PEARL CT. Allendale, NJ 07401 |
| Product Code | EXY |
| CFR Regulation Number | 876.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-08-24 |
| Decision Date | 1995-11-21 |