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FDA 510(k)

NOVEON MODEL LS1100-03

K-Number: K083476 · 2008-12-22

ApplicantNomir Medical Technologies, Inc.
Decision Date2008-12-22
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

NOVEON MODEL LS1100-03 is the device name listed in this FDA 510(k) record. The listed applicant is Nomir Medical Technologies, Inc.. It received FDA 510(k) clearance on 2008-12-22 under 510(k) number K083476. 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 NOVEON MODEL LS1100-03?

NOVEON MODEL LS1100-03 is a medical device that received FDA 510(k) clearance on 2008-12-22. The listed applicant is Nomir Medical Technologies, Inc.. The 510(k) number is K083476.

When did NOVEON MODEL LS1100-03 receive FDA 510(k) clearance?

NOVEON MODEL LS1100-03 received FDA 510(k) clearance on 2008-12-22, under 510(k) number K083476.

Who is the listed applicant for NOVEON MODEL LS1100-03?

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

What is the FDA product code for NOVEON MODEL LS1100-03?

The FDA product code for NOVEON MODEL LS1100-03 is GEX. This falls under the Gastroenterology category.

Related Clinical Trials

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Other records listing Nomir Medical 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.

K071815NOVEON, MODEL LS1100-01-0968

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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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