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 |