The following data is part of a premarket notification filed by Dantec Electronics, Inc. with the FDA for Urdyn 5000 (uroflowmeter).
| Device ID | K860368 |
| 510k Number | K860368 |
| Device Name: | URDYN 5000 (UROFLOWMETER) |
| Classification | Retractor, Self-retaining |
| Applicant | DANTEC ELECTRONICS, INC. 6 PEARL COURT Allendale, NJ 07401 |
| Contact | Henrik Henriksen |
| Correspondent | Henrik Henriksen DANTEC ELECTRONICS, INC. 6 PEARL COURT Allendale, NJ 07401 |
| Product Code | FFO |
| CFR Regulation Number | 876.4730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-02-03 |
| Decision Date | 1986-04-23 |