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FDA 510(k)

CLARO

K-Number: K080638 · 2008-09-17

ApplicantClrs Technology Corporation
Decision Date2008-09-17
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CLARO is the device name listed in this FDA 510(k) record. The listed applicant is Clrs Technology Corporation. It received FDA 510(k) clearance on 2008-09-17 under 510(k) number K080638. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CLARO?

CLARO is a medical device that received FDA 510(k) clearance on 2008-09-17. The listed applicant is Clrs Technology Corporation. The 510(k) number is K080638.

When did CLARO receive FDA 510(k) clearance?

CLARO received FDA 510(k) clearance on 2008-09-17, under 510(k) number K080638.

Who is the listed applicant for CLARO?

The FDA 510(k) record lists Clrs Technology Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CLARO?

The FDA product code for CLARO is GEX. This falls under the Gastroenterology category.

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Other records listing Clrs Technology Corporation 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.

K090744CLARO

Related Devices (Code: GEX)

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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