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 |