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FDA 510(k)

ICE-SENSE

K-Number: K072883 · 2007-12-10

ApplicantArbel Medical , Ltd.
Decision Date2007-12-10
Product CodeGEH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ICE-SENSE is the device name listed in this FDA 510(k) record. The listed applicant is Arbel Medical , Ltd.. It received FDA 510(k) clearance on 2007-12-10 under 510(k) number K072883. 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 ICE-SENSE?

ICE-SENSE is a medical device that received FDA 510(k) clearance on 2007-12-10. The listed applicant is Arbel Medical , Ltd.. The 510(k) number is K072883.

When did ICE-SENSE receive FDA 510(k) clearance?

ICE-SENSE received FDA 510(k) clearance on 2007-12-10, under 510(k) number K072883.

Who is the listed applicant for ICE-SENSE?

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

What is the FDA product code for ICE-SENSE?

The FDA product code for ICE-SENSE 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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