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FDA 510(k)

CRYOFLOW 700, CRYOFLOW 1000

K-Number: K052310 · 2006-03-15

ApplicantUniphy Elektromedizin GmbH & Co. KG
Decision Date2006-03-15
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CRYOFLOW 700, CRYOFLOW 1000 is the device name listed in this FDA 510(k) record. The listed applicant is Uniphy Elektromedizin GmbH & Co. KG. It received FDA 510(k) clearance on 2006-03-15 under 510(k) number K052310. 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 CRYOFLOW 700, CRYOFLOW 1000?

CRYOFLOW 700, CRYOFLOW 1000 is a medical device that received FDA 510(k) clearance on 2006-03-15. The listed applicant is Uniphy Elektromedizin GmbH & Co. KG. The 510(k) number is K052310.

When did CRYOFLOW 700, CRYOFLOW 1000 receive FDA 510(k) clearance?

CRYOFLOW 700, CRYOFLOW 1000 received FDA 510(k) clearance on 2006-03-15, under 510(k) number K052310.

Who is the listed applicant for CRYOFLOW 700, CRYOFLOW 1000?

The FDA 510(k) record lists Uniphy Elektromedizin GmbH & Co. KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CRYOFLOW 700, CRYOFLOW 1000?

The FDA product code for CRYOFLOW 700, CRYOFLOW 1000 is GEX. This falls under the Gastroenterology category.

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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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