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FDA 510(k)

CRYO-HIT, MODELS EP6T5, FP5T5, FP5T3, EP2T2, EP1T1, AND EP2T1

K-Number: K012497 · 2001-10-30

ApplicantGalil Medical , Ltd.
Decision Date2001-10-30
Product CodeGEH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CRYO-HIT, MODELS EP6T5, FP5T5, FP5T3, EP2T2, EP1T1, AND EP2T1 is the device name listed in this FDA 510(k) record. The listed applicant is Galil Medical , Ltd.. It received FDA 510(k) clearance on 2001-10-30 under 510(k) number K012497. 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 CRYO-HIT, MODELS EP6T5, FP5T5, FP5T3, EP2T2, EP1T1, AND EP2T1?

CRYO-HIT, MODELS EP6T5, FP5T5, FP5T3, EP2T2, EP1T1, AND EP2T1 is a medical device that received FDA 510(k) clearance on 2001-10-30. The listed applicant is Galil Medical , Ltd.. The 510(k) number is K012497.

When did CRYO-HIT, MODELS EP6T5, FP5T5, FP5T3, EP2T2, EP1T1, AND EP2T1 receive FDA 510(k) clearance?

CRYO-HIT, MODELS EP6T5, FP5T5, FP5T3, EP2T2, EP1T1, AND EP2T1 received FDA 510(k) clearance on 2001-10-30, under 510(k) number K012497.

Who is the listed applicant for CRYO-HIT, MODELS EP6T5, FP5T5, FP5T3, EP2T2, EP1T1, AND EP2T1?

The FDA 510(k) record lists Galil Medical , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CRYO-HIT, MODELS EP6T5, FP5T5, FP5T3, EP2T2, EP1T1, AND EP2T1?

The FDA product code for CRYO-HIT, MODELS EP6T5, FP5T5, FP5T3, EP2T2, EP1T1, AND EP2T1 is GEH.

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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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