CryoVizion System

Device, Sensing, Optical Contour

Cryos Technologies Inc.

The following data is part of a premarket notification filed by Cryos Technologies Inc. with the FDA for Cryovizion System.

Pre-market Notification Details

Device IDK183485
510k NumberK183485
Device Name:CryoVizion System
ClassificationDevice, Sensing, Optical Contour
Applicant Cryos Technologies Inc. 385 Rue Salaberry Joliette,  CA J6e 4g4
ContactJohn A. Stimpson
CorrespondentLouis-paul Martin
LOK North America Inc. 2025 Rue Michelin Laval,  CA H7l 5b7
Product CodeLDK  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-12-17
Decision Date2019-08-28

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