NICKI, MODEL NUMBER USD-NK-UP1

Cystometric Gas (carbon-dioxide) On Hydraulic Device

LABORIE MEDICAL TECHNOLOGIES, LTD.

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.

Pre-market Notification Details

Device IDK924086
510k NumberK924086
Device Name:NICKI, MODEL NUMBER USD-NK-UP1
ClassificationCystometric Gas (carbon-dioxide) On Hydraulic Device
Applicant LABORIE MEDICAL TECHNOLOGIES, LTD. 45 WEST ST. SUITE 2 Attleboro,  MA  02703
ContactJames R Veale
CorrespondentJames R Veale
LABORIE MEDICAL TECHNOLOGIES, LTD. 45 WEST ST. SUITE 2 Attleboro,  MA  02703
Product CodeFAP  
CFR Regulation Number876.1620 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-08-13
Decision Date1992-10-20

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