The following data is part of a premarket notification filed by Laborie Medical Technologies, Ltd. with the FDA for Nicki, Model Number Usd-nk-up1.
| Device ID | K924086 |
| 510k Number | K924086 |
| Device Name: | NICKI, MODEL NUMBER USD-NK-UP1 |
| Classification | Cystometric Gas (carbon-dioxide) On Hydraulic Device |
| Applicant | LABORIE MEDICAL TECHNOLOGIES, LTD. 45 WEST ST. SUITE 2 Attleboro, MA 02703 |
| Contact | James R Veale |
| Correspondent | James R Veale LABORIE MEDICAL TECHNOLOGIES, LTD. 45 WEST ST. SUITE 2 Attleboro, MA 02703 |
| Product Code | FAP |
| CFR Regulation Number | 876.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-08-13 |
| Decision Date | 1992-10-20 |