The following data is part of a premarket notification filed by Laborie Medical Tech, Inc. with the FDA for Uorcap,model Number Uds-ucap.
| Device ID | K941105 |
| 510k Number | K941105 |
| Device Name: | UORCAP,MODEL NUMBER UDS-UCAP |
| Classification | Uroflowmeter |
| Applicant | LABORIE MEDICAL TECH, INC. 6415 NORTHWEST DR., UNIT 11 Mississauga, Ontario, CA L4v 1x1 |
| Contact | Fred Buffa |
| Correspondent | Fred Buffa LABORIE MEDICAL TECH, INC. 6415 NORTHWEST DR., UNIT 11 Mississauga, Ontario, CA L4v 1x1 |
| Product Code | EXY |
| CFR Regulation Number | 876.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-03-07 |
| Decision Date | 1994-05-10 |