FDA 510(k)

CRYO-HIT MODEL NUMBERS EP3T3, EP5T2, EP5T5, EP7T5, EP8T5

K-Number: K980913 · 1998-07-01

Decision Date1998-07-01

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

CRYO-HIT MODEL NUMBERS EP3T3, EP5T2, EP5T5, EP7T5, EP8T5 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 1998-07-01 under 510(k) number K980913. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CRYO-HIT MODEL NUMBERS EP3T3, EP5T2, EP5T5, EP7T5, EP8T5?

CRYO-HIT MODEL NUMBERS EP3T3, EP5T2, EP5T5, EP7T5, EP8T5 is a medical device that received FDA 510(k) clearance on 1998-07-01. The listed applicant is Galil Medical , Ltd.. The 510(k) number is K980913.

When did CRYO-HIT MODEL NUMBERS EP3T3, EP5T2, EP5T5, EP7T5, EP8T5 receive FDA 510(k) clearance?

CRYO-HIT MODEL NUMBERS EP3T3, EP5T2, EP5T5, EP7T5, EP8T5 received FDA 510(k) clearance on 1998-07-01, under 510(k) number K980913.

Who is the listed applicant for CRYO-HIT MODEL NUMBERS EP3T3, EP5T2, EP5T5, EP7T5, EP8T5?

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 MODEL NUMBERS EP3T3, EP5T2, EP5T5, EP7T5, EP8T5?

The FDA product code for CRYO-HIT MODEL NUMBERS EP3T3, EP5T2, EP5T5, EP7T5, EP8T5 is GEI.

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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.