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FDA 510(k)

AL-40

K-Number: K010715 · 2001-10-04

ApplicantDdc Technologies, Inc.
Decision Date2001-10-04
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

AL-40 is the device name listed in this FDA 510(k) record. The listed applicant is Ddc Technologies, Inc.. It received FDA 510(k) clearance on 2001-10-04 under 510(k) number K010715. 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 AL-40?

AL-40 is a medical device that received FDA 510(k) clearance on 2001-10-04. The listed applicant is Ddc Technologies, Inc.. The 510(k) number is K010715.

When did AL-40 receive FDA 510(k) clearance?

AL-40 received FDA 510(k) clearance on 2001-10-04, under 510(k) number K010715.

Who is the listed applicant for AL-40?

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

What is the FDA product code for AL-40?

The FDA product code for AL-40 is GEX. This falls under the Gastroenterology category.

Other records listing Ddc Technologies, Inc. as applicant

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.

K253765VANISH PROK040055POLYLASE LPK020513EPY-50

Related Devices (Code: GEX)

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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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