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FDA 510(k)

MAXONE, BLOOD, BLOOD PRODUCTS AND IV FLUID WARMER

K-Number: K002409 · 2001-06-28

ApplicantAutomatic Medical Technologies, Inc.
Decision Date2001-06-28
Product CodeLGZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MAXONE, BLOOD, BLOOD PRODUCTS AND IV FLUID WARMER is the device name listed in this FDA 510(k) record. The listed applicant is Automatic Medical Technologies, Inc.. It received FDA 510(k) clearance on 2001-06-28 under 510(k) number K002409. 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 MAXONE, BLOOD, BLOOD PRODUCTS AND IV FLUID WARMER?

MAXONE, BLOOD, BLOOD PRODUCTS AND IV FLUID WARMER is a medical device that received FDA 510(k) clearance on 2001-06-28. The listed applicant is Automatic Medical Technologies, Inc.. The 510(k) number is K002409.

When did MAXONE, BLOOD, BLOOD PRODUCTS AND IV FLUID WARMER receive FDA 510(k) clearance?

MAXONE, BLOOD, BLOOD PRODUCTS AND IV FLUID WARMER received FDA 510(k) clearance on 2001-06-28, under 510(k) number K002409.

Who is the listed applicant for MAXONE, BLOOD, BLOOD PRODUCTS AND IV FLUID WARMER?

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

What is the FDA product code for MAXONE, BLOOD, BLOOD PRODUCTS AND IV FLUID WARMER?

The FDA product code for MAXONE, BLOOD, BLOOD PRODUCTS AND IV FLUID WARMER is LGZ.

Related Clinical Trials

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.

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Other records listing Automatic 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.

K023653MAXONE IV FLUID/BLOOD WARMER, MODEL 102

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

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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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