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FDA 510(k)

CRYOTRON 2 CRYOTHERAPY DEVICE

K-Number: K030281 · 2003-08-20

ApplicantCryonic Medical North America
Decision Date2003-08-20
Product CodeMLY
DecisionSubstantially Equivalent

Device Summary

CRYOTRON 2 CRYOTHERAPY DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Cryonic Medical North America. It received FDA 510(k) clearance on 2003-08-20 under 510(k) number K030281. The device is classified under product code MLY. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CRYOTRON 2 CRYOTHERAPY DEVICE?

CRYOTRON 2 CRYOTHERAPY DEVICE is a medical device that received FDA 510(k) clearance on 2003-08-20. The listed applicant is Cryonic Medical North America. The 510(k) number is K030281.

When did CRYOTRON 2 CRYOTHERAPY DEVICE receive FDA 510(k) clearance?

CRYOTRON 2 CRYOTHERAPY DEVICE received FDA 510(k) clearance on 2003-08-20, under 510(k) number K030281.

Who is the listed applicant for CRYOTRON 2 CRYOTHERAPY DEVICE?

The FDA 510(k) record lists Cryonic Medical North America as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CRYOTRON 2 CRYOTHERAPY DEVICE?

The FDA product code for CRYOTRON 2 CRYOTHERAPY DEVICE is MLY.

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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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