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FDA 510(k)

CRYO, MODEL V6.0

K-Number: K060395 · 2006-02-24

ApplicantZimmer Elektromedizin GmbH
Decision Date2006-02-24
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CRYO, MODEL V6.0 is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer Elektromedizin GmbH. It received FDA 510(k) clearance on 2006-02-24 under 510(k) number K060395. 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 CRYO, MODEL V6.0?

CRYO, MODEL V6.0 is a medical device that received FDA 510(k) clearance on 2006-02-24. The listed applicant is Zimmer Elektromedizin GmbH. The 510(k) number is K060395.

When did CRYO, MODEL V6.0 receive FDA 510(k) clearance?

CRYO, MODEL V6.0 received FDA 510(k) clearance on 2006-02-24, under 510(k) number K060395.

Who is the listed applicant for CRYO, MODEL V6.0?

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

What is the FDA product code for CRYO, MODEL V6.0?

The FDA product code for CRYO, MODEL V6.0 is GEX. This falls under the Gastroenterology category.

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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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