The following data is part of a premarket notification filed by Mct Medical, Inc. with the FDA for Mct Medical Browne Uroscan Urodynamic.
| Device ID | K880504 |
| 510k Number | K880504 |
| Device Name: | MCT MEDICAL BROWNE UROSCAN URODYNAMIC |
| Classification | Uroflowmeter |
| Applicant | MCT MEDICAL, INC. 599 CARDIGAN RD. P.O. BOX 64022 Shoreview, MN 55126 |
| Contact | Nancy J Popp |
| Correspondent | Nancy J Popp MCT MEDICAL, INC. 599 CARDIGAN RD. P.O. BOX 64022 Shoreview, MN 55126 |
| Product Code | EXY |
| CFR Regulation Number | 876.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-02-05 |
| Decision Date | 1988-06-17 |