510(k) K183485
K183485 is an FDA 510(k) premarket notification submitted by Cryos Technologies, Inc. for the device "CryoVizion System". The FDA issued a decision of Substantially Equivalent on August 28, 2019. The device falls under product code LDK (Device, Sensing, Optical Contour), a Class U device.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 28, 2019
- Date Received
- December 17, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Sensing, Optical Contour
- Device Class
- Class U
- Regulation Number
- Review Panel
- PM
- Submission Type