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FDA 510(k)

NEO-MED DLS-1100

K-Number: K954931 · 1995-12-18

ApplicantNeo-Laboratories, LLC
Decision Date1995-12-18
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

NEO-MED DLS-1100 is the device name listed in this FDA 510(k) record. The listed applicant is Neo-Laboratories, LLC. It received FDA 510(k) clearance on 1995-12-18 under 510(k) number K954931. 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 NEO-MED DLS-1100?

NEO-MED DLS-1100 is a medical device that received FDA 510(k) clearance on 1995-12-18. The listed applicant is Neo-Laboratories, LLC. The 510(k) number is K954931.

When did NEO-MED DLS-1100 receive FDA 510(k) clearance?

NEO-MED DLS-1100 received FDA 510(k) clearance on 1995-12-18, under 510(k) number K954931.

Who is the listed applicant for NEO-MED DLS-1100?

The FDA 510(k) record lists Neo-Laboratories, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NEO-MED DLS-1100?

The FDA product code for NEO-MED DLS-1100 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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