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FDA 510(k)

NLITE SYSTEM, SLS MODEL NUMBER A00-1025

K-Number: K000811 · 2000-08-25

ApplicantSls Biophile , Ltd.
Decision Date2000-08-25
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

NLITE SYSTEM, SLS MODEL NUMBER A00-1025 is the device name listed in this FDA 510(k) record. The listed applicant is Sls Biophile , Ltd.. It received FDA 510(k) clearance on 2000-08-25 under 510(k) number K000811. 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 NLITE SYSTEM, SLS MODEL NUMBER A00-1025?

NLITE SYSTEM, SLS MODEL NUMBER A00-1025 is a medical device that received FDA 510(k) clearance on 2000-08-25. The listed applicant is Sls Biophile , Ltd.. The 510(k) number is K000811.

When did NLITE SYSTEM, SLS MODEL NUMBER A00-1025 receive FDA 510(k) clearance?

NLITE SYSTEM, SLS MODEL NUMBER A00-1025 received FDA 510(k) clearance on 2000-08-25, under 510(k) number K000811.

Who is the listed applicant for NLITE SYSTEM, SLS MODEL NUMBER A00-1025?

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

What is the FDA product code for NLITE SYSTEM, SLS MODEL NUMBER A00-1025?

The FDA product code for NLITE SYSTEM, SLS MODEL NUMBER A00-1025 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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