The following data is part of a premarket notification filed by Laborie Medical Technologies, Ltd. with the FDA for Advance Model Uds-adv.
| Device ID | K931574 |
| 510k Number | K931574 |
| Device Name: | ADVANCE MODEL UDS-ADV |
| Classification | Cystometer, Electrical Recording |
| Applicant | LABORIE MEDICAL TECHNOLOGIES, LTD. 6415 NORTHWEST DR. UNIT #11 Mississauga, Ontario, CA L4v 1x1 |
| Contact | Fred Buffa |
| Correspondent | Fred Buffa LABORIE MEDICAL TECHNOLOGIES, LTD. 6415 NORTHWEST DR. UNIT #11 Mississauga, Ontario, CA L4v 1x1 |
| Product Code | EXQ |
| CFR Regulation Number | 876.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-03-30 |
| Decision Date | 1993-08-05 |