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FDA 510(k)

CryoLab

K-Number: K190407 · 2019-04-22

ApplicantCryoconcepts LP
Decision Date2019-04-22
Product CodeGEH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CryoLab is a medical device manufactured by Cryoconcepts LP. It received FDA 510(k) clearance on 2019-04-22 under approval number K190407. 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 CryoLab?

CryoLab is a medical device that received FDA 510(k) clearance on 2019-04-22. It is manufactured by Cryoconcepts LP. The 510(k) number is K190407.

When was CryoLab approved by the FDA?

CryoLab received FDA 510(k) clearance on 2019-04-22, under approval number K190407.

What company makes CryoLab?

CryoLab is manufactured by Cryoconcepts LP.

What is the FDA product code for CryoLab?

The FDA product code for CryoLab is GEH.

Other Devices by Cryoconcepts LP

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Official Source

View on FDA Database →

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

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