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FDA 510(k)

CLARISCT

K-Number: K120753 · 2012-07-26

ApplicantIcrco, Inc.
Decision Date2012-07-26
Product CodeOAS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CLARISCT is the device name listed in this FDA 510(k) record. The listed applicant is Icrco, Inc.. It received FDA 510(k) clearance on 2012-07-26 under 510(k) number K120753. The device is classified under product code OAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CLARISCT?

CLARISCT is a medical device that received FDA 510(k) clearance on 2012-07-26. The listed applicant is Icrco, Inc.. The 510(k) number is K120753.

When did CLARISCT receive FDA 510(k) clearance?

CLARISCT received FDA 510(k) clearance on 2012-07-26, under 510(k) number K120753.

Who is the listed applicant for CLARISCT?

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

What is the FDA product code for CLARISCT?

The FDA product code for CLARISCT is OAS.

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Other records listing Icrco, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K122510ICRCO 3600MK113449FUSION FLAT PANELK082450IDR

Related Devices (Code: OAS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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