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FDA 510(k)

RANGER RAPID FLOW BLOOD/FLUID WARMING SYSTEM

K-Number: K082217 · 2008-10-06

ApplicantArizant Healthcare, Inc.
Decision Date2008-10-06
Product CodeLGZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

RANGER RAPID FLOW BLOOD/FLUID WARMING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Arizant Healthcare, Inc.. It received FDA 510(k) clearance on 2008-10-06 under 510(k) number K082217. 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 RANGER RAPID FLOW BLOOD/FLUID WARMING SYSTEM?

RANGER RAPID FLOW BLOOD/FLUID WARMING SYSTEM is a medical device that received FDA 510(k) clearance on 2008-10-06. The listed applicant is Arizant Healthcare, Inc.. The 510(k) number is K082217.

When did RANGER RAPID FLOW BLOOD/FLUID WARMING SYSTEM receive FDA 510(k) clearance?

RANGER RAPID FLOW BLOOD/FLUID WARMING SYSTEM received FDA 510(k) clearance on 2008-10-06, under 510(k) number K082217.

Who is the listed applicant for RANGER RAPID FLOW BLOOD/FLUID WARMING SYSTEM?

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

What is the FDA product code for RANGER RAPID FLOW BLOOD/FLUID WARMING SYSTEM?

The FDA product code for RANGER RAPID FLOW BLOOD/FLUID WARMING SYSTEM 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 Arizant Healthcare, 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.

K1204123M SPOTON TEMPERATURE MONITORING SYSTEMK060939RANGER IRRIGATION FLUID WARMING SYSTEMK060865BAIR PAWS TEMPERATURE MANAGEMENT SYSTEM MODEL 850K053645MODIFICATION TO:BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEMSK041686BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEM

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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