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FDA 510(k)

ISIS

K-Number: K070482 · 2007-03-20

ApplicantGalil Medical , Ltd.
Decision Date2007-03-20
Product CodeGEH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ISIS 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 2007-03-20 under 510(k) number K070482. 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 ISIS?

ISIS is a medical device that received FDA 510(k) clearance on 2007-03-20. The listed applicant is Galil Medical , Ltd.. The 510(k) number is K070482.

When did ISIS receive FDA 510(k) clearance?

ISIS received FDA 510(k) clearance on 2007-03-20, under 510(k) number K070482.

Who is the listed applicant for ISIS?

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 ISIS?

The FDA product code for ISIS 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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