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FDA 510(k)

CRYOFOS

K-Number: K170810 · 2017-09-27

ApplicantCryofos Medical GmbH
Decision Date2017-09-27
Product CodeGEH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CRYOFOS is a medical device manufactured by Cryofos Medical GmbH. It received FDA 510(k) clearance on 2017-09-27 under approval number K170810. The device is classified under product code GEH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CRYOFOS?

CRYOFOS is a medical device that received FDA 510(k) clearance on 2017-09-27. It is manufactured by Cryofos Medical GmbH. The 510(k) number is K170810.

When was CRYOFOS approved by the FDA?

CRYOFOS received FDA 510(k) clearance on 2017-09-27, under approval number K170810.

What company makes CRYOFOS?

CRYOFOS is manufactured by Cryofos Medical GmbH.

What is the FDA product code for CRYOFOS?

The FDA product code for CRYOFOS is GEH.

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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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