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 |