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FDA 510(k)

FOX 940, MODEL 940

K-Number: K071896 · 2008-02-22

ApplicantValam, Inc.
Decision Date2008-02-22
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

FOX 940, MODEL 940 is the device name listed in this FDA 510(k) record. The listed applicant is Valam, Inc.. It received FDA 510(k) clearance on 2008-02-22 under 510(k) number K071896. 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 FOX 940, MODEL 940?

FOX 940, MODEL 940 is a medical device that received FDA 510(k) clearance on 2008-02-22. The listed applicant is Valam, Inc.. The 510(k) number is K071896.

When did FOX 940, MODEL 940 receive FDA 510(k) clearance?

FOX 940, MODEL 940 received FDA 510(k) clearance on 2008-02-22, under 510(k) number K071896.

Who is the listed applicant for FOX 940, MODEL 940?

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

What is the FDA product code for FOX 940, MODEL 940?

The FDA product code for FOX 940, MODEL 940 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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