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FDA 510(k)

MD 30 COMPACT

K-Number: K004014 · 2001-03-16

ApplicantGeneral Project
Decision Date2001-03-16
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MD 30 COMPACT is the device name listed in this FDA 510(k) record. The listed applicant is General Project. It received FDA 510(k) clearance on 2001-03-16 under 510(k) number K004014. 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 MD 30 COMPACT?

MD 30 COMPACT is a medical device that received FDA 510(k) clearance on 2001-03-16. The listed applicant is General Project. The 510(k) number is K004014.

When did MD 30 COMPACT receive FDA 510(k) clearance?

MD 30 COMPACT received FDA 510(k) clearance on 2001-03-16, under 510(k) number K004014.

Who is the listed applicant for MD 30 COMPACT?

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

What is the FDA product code for MD 30 COMPACT?

The FDA product code for MD 30 COMPACT 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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