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FDA 510(k)

CRYOPEN AND ACCESSORIES

K-Number: K012214 · 2002-04-26

ApplicantCimex Biotech, LLC
Decision Date2002-04-26
Product CodeGEH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CRYOPEN AND ACCESSORIES is the device name listed in this FDA 510(k) record. The listed applicant is Cimex Biotech, LLC. It received FDA 510(k) clearance on 2002-04-26 under 510(k) number K012214. 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 CRYOPEN AND ACCESSORIES?

CRYOPEN AND ACCESSORIES is a medical device that received FDA 510(k) clearance on 2002-04-26. The listed applicant is Cimex Biotech, LLC. The 510(k) number is K012214.

When did CRYOPEN AND ACCESSORIES receive FDA 510(k) clearance?

CRYOPEN AND ACCESSORIES received FDA 510(k) clearance on 2002-04-26, under 510(k) number K012214.

Who is the listed applicant for CRYOPEN AND ACCESSORIES?

The FDA 510(k) record lists Cimex Biotech, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CRYOPEN AND ACCESSORIES?

The FDA product code for CRYOPEN AND ACCESSORIES 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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