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FDA 510(k)

CryoVizion System

K-Number: K183485 · 2019-08-28

ApplicantCryos Technologies, Inc.
Decision Date2019-08-28
Product CodeLDK
DecisionSubstantially Equivalent

Device Summary

CryoVizion System is a medical device manufactured by Cryos Technologies, Inc.. It received FDA 510(k) clearance on 2019-08-28 under approval number K183485. The device is classified under product code LDK. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CryoVizion System?

CryoVizion System is a medical device that received FDA 510(k) clearance on 2019-08-28. It is manufactured by Cryos Technologies, Inc.. The 510(k) number is K183485.

When was CryoVizion System approved by the FDA?

CryoVizion System received FDA 510(k) clearance on 2019-08-28, under approval number K183485.

What company makes CryoVizion System?

CryoVizion System is manufactured by Cryos Technologies, Inc..

What is the FDA product code for CryoVizion System?

The FDA product code for CryoVizion System is LDK.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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