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FDA 510(k)

HYPOTHERMX INTRAVENOUS FLUID WARMER

K-Number: K103801 · 2011-05-20

ApplicantEmit Corporation
Decision Date2011-05-20
Product CodeLGZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

HYPOTHERMX INTRAVENOUS FLUID WARMER is the device name listed in this FDA 510(k) record. The listed applicant is Emit Corporation. It received FDA 510(k) clearance on 2011-05-20 under 510(k) number K103801. 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 HYPOTHERMX INTRAVENOUS FLUID WARMER?

HYPOTHERMX INTRAVENOUS FLUID WARMER is a medical device that received FDA 510(k) clearance on 2011-05-20. The listed applicant is Emit Corporation. The 510(k) number is K103801.

When did HYPOTHERMX INTRAVENOUS FLUID WARMER receive FDA 510(k) clearance?

HYPOTHERMX INTRAVENOUS FLUID WARMER received FDA 510(k) clearance on 2011-05-20, under 510(k) number K103801.

Who is the listed applicant for HYPOTHERMX INTRAVENOUS FLUID WARMER?

The FDA 510(k) record lists Emit Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HYPOTHERMX INTRAVENOUS FLUID WARMER?

The FDA product code for HYPOTHERMX INTRAVENOUS FLUID WARMER is LGZ.

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Related Devices (Code: LGZ)

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.

K262532NORMOFLO™ Irrigation Fluid Warming Sets and Accessories (IR-601, IR-501, IR-61, PL-61)ICU MedicalK260988°M Warmer System with °M StationMequ A/SK252636Fluido Compact SystemThe Surgical Company International B.V.K251733Fluido® AirGuard SystemThe Surgical Company International BV (As Tsc Life)K232107°M Warmer SystemMequ A/SK211618Fluido Compact Blood and Fluid Warming SystemThe Surgical Company International B.V.

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.

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