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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 the device name listed in this FDA 510(k) record. The listed applicant is Cryos Technologies, Inc.. It received FDA 510(k) clearance on 2019-08-28 under 510(k) 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. The listed applicant is Cryos Technologies, Inc.. The 510(k) number is K183485.

When did CryoVizion System receive FDA 510(k) clearance?

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

Who is the listed applicant for CryoVizion System?

The FDA 510(k) record lists Cryos Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

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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