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FDA 510(k)

DC SERIES FLUID WARMING CABINET, DC SERIES FLUID WARMING CABINET

K-Number: K132202 · 2013-12-06

ApplicantEnthermics Medical Systems, Inc.
Decision Date2013-12-06
Product CodeLGZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

DC SERIES FLUID WARMING CABINET, DC SERIES FLUID WARMING CABINET is the device name listed in this FDA 510(k) record. The listed applicant is Enthermics Medical Systems, Inc.. It received FDA 510(k) clearance on 2013-12-06 under 510(k) number K132202. 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 DC SERIES FLUID WARMING CABINET, DC SERIES FLUID WARMING CABINET?

DC SERIES FLUID WARMING CABINET, DC SERIES FLUID WARMING CABINET is a medical device that received FDA 510(k) clearance on 2013-12-06. The listed applicant is Enthermics Medical Systems, Inc.. The 510(k) number is K132202.

When did DC SERIES FLUID WARMING CABINET, DC SERIES FLUID WARMING CABINET receive FDA 510(k) clearance?

DC SERIES FLUID WARMING CABINET, DC SERIES FLUID WARMING CABINET received FDA 510(k) clearance on 2013-12-06, under 510(k) number K132202.

Who is the listed applicant for DC SERIES FLUID WARMING CABINET, DC SERIES FLUID WARMING CABINET?

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

What is the FDA product code for DC SERIES FLUID WARMING CABINET, DC SERIES FLUID WARMING CABINET?

The FDA product code for DC SERIES FLUID WARMING CABINET, DC SERIES FLUID WARMING CABINET 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Enthermics Medical Systems, 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.

K091336IVNOW MODULAR FLUID WARMER, 120V, MODEL IVNOW-1, IVNOW-2, IVNOW-3, IVNOW-6, IVNOW MODULAR FLUID WARMER 230VK993797EC-7701 FLUID WARMING CABINETK963731TRU-5000 THERMAL RECOVERY RADIANT HEATING UNIT

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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