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FDA 510(k)

CRYO 5

K-Number: K040727 · 2004-04-23

ApplicantZimmer Elektromedizin GmbH
Decision Date2004-04-23
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CRYO 5 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 2004-04-23 under 510(k) number K040727. 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 5?

CRYO 5 is a medical device that received FDA 510(k) clearance on 2004-04-23. The listed applicant is Zimmer Elektromedizin GmbH. The 510(k) number is K040727.

When did CRYO 5 receive FDA 510(k) clearance?

CRYO 5 received FDA 510(k) clearance on 2004-04-23, under 510(k) number K040727.

Who is the listed applicant for CRYO 5?

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 5?

The FDA product code for CRYO 5 is GEX. This falls under the Gastroenterology category.

Other records listing Zimmer Elektromedizin GmbH as applicant

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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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