FDA 510(k)

NORMOFLO IRRIGATION FLUID WARMER, MODELS H-1100, H-1129, NORMOFLO IRRIGATION WARMING SET, MODELS, IR-40, IR-500, IR-600,

K-Number: K072080 · 2008-06-02

Decision Date2008-06-02

Product CodeLGZ

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

NORMOFLO IRRIGATION FLUID WARMER, MODELS H-1100, H-1129, NORMOFLO IRRIGATION WARMING SET, MODELS, IR-40, IR-500, IR-600, is the device name listed in this FDA 510(k) record. The listed applicant is Smiths Medical Asd, Inc.. It received FDA 510(k) clearance on 2008-06-02 under 510(k) number K072080. The device is classified under product code LGZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NORMOFLO IRRIGATION FLUID WARMER, MODELS H-1100, H-1129, NORMOFLO IRRIGATION WARMING SET, MODELS, IR-40, IR-500, IR-600,?

NORMOFLO IRRIGATION FLUID WARMER, MODELS H-1100, H-1129, NORMOFLO IRRIGATION WARMING SET, MODELS, IR-40, IR-500, IR-600, is a medical device that received FDA 510(k) clearance on 2008-06-02. The listed applicant is Smiths Medical Asd, Inc.. The 510(k) number is K072080.

When did NORMOFLO IRRIGATION FLUID WARMER, MODELS H-1100, H-1129, NORMOFLO IRRIGATION WARMING SET, MODELS, IR-40, IR-500, IR-600, receive FDA 510(k) clearance?

NORMOFLO IRRIGATION FLUID WARMER, MODELS H-1100, H-1129, NORMOFLO IRRIGATION WARMING SET, MODELS, IR-40, IR-500, IR-600, received FDA 510(k) clearance on 2008-06-02, under 510(k) number K072080.

Who is the listed applicant for NORMOFLO IRRIGATION FLUID WARMER, MODELS H-1100, H-1129, NORMOFLO IRRIGATION WARMING SET, MODELS, IR-40, IR-500, IR-600,?

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

What is the FDA product code for NORMOFLO IRRIGATION FLUID WARMER, MODELS H-1100, H-1129, NORMOFLO IRRIGATION WARMING SET, MODELS, IR-40, IR-500, IR-600,?

The FDA product code for NORMOFLO IRRIGATION FLUID WARMER, MODELS H-1100, H-1129, NORMOFLO IRRIGATION WARMING SET, MODELS, IR-40, IR-500, IR-600, is LGZ.

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Related Devices (Code: LGZ)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.