The following data is part of a premarket notification filed by Cryos Technologies Inc. with the FDA for Cryovizion System.
Device ID | K183485 |
510k Number | K183485 |
Device Name: | CryoVizion System |
Classification | Device, Sensing, Optical Contour |
Applicant | Cryos Technologies Inc. 385 Rue Salaberry Joliette, CA J6e 4g4 |
Contact | John A. Stimpson |
Correspondent | Louis-paul Martin LOK North America Inc. 2025 Rue Michelin Laval, CA H7l 5b7 |
Product Code | LDK |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-12-17 |
Decision Date | 2019-08-28 |