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FDA 510(k)

FLASH 1

K-Number: K022583 · 2002-10-31

ApplicantEmed, Inc.
Decision Date2002-10-31
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

FLASH 1 is the device name listed in this FDA 510(k) record. The listed applicant is Emed, Inc.. It received FDA 510(k) clearance on 2002-10-31 under 510(k) number K022583. 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 FLASH 1?

FLASH 1 is a medical device that received FDA 510(k) clearance on 2002-10-31. The listed applicant is Emed, Inc.. The 510(k) number is K022583.

When did FLASH 1 receive FDA 510(k) clearance?

FLASH 1 received FDA 510(k) clearance on 2002-10-31, under 510(k) number K022583.

Who is the listed applicant for FLASH 1?

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

What is the FDA product code for FLASH 1?

The FDA product code for FLASH 1 is GEX. This falls under the Gastroenterology category.

Related Clinical Trials

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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