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FDA 510(k)

INTRATEMP SOLUTION WARMER

K-Number: K083417 · 2009-01-13

ApplicantC Change Surgical, LLC
Decision Date2009-01-13
Product CodeLHC
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

INTRATEMP SOLUTION WARMER is the device name listed in this FDA 510(k) record. The listed applicant is C Change Surgical, LLC. It received FDA 510(k) clearance on 2009-01-13 under 510(k) number K083417. The device is classified under product code LHC. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTRATEMP SOLUTION WARMER?

INTRATEMP SOLUTION WARMER is a medical device that received FDA 510(k) clearance on 2009-01-13. The listed applicant is C Change Surgical, LLC. The 510(k) number is K083417.

When did INTRATEMP SOLUTION WARMER receive FDA 510(k) clearance?

INTRATEMP SOLUTION WARMER received FDA 510(k) clearance on 2009-01-13, under 510(k) number K083417.

Who is the listed applicant for INTRATEMP SOLUTION WARMER?

The FDA 510(k) record lists C Change Surgical, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INTRATEMP SOLUTION WARMER?

The FDA product code for INTRATEMP SOLUTION WARMER is LHC.

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 C Change Surgical, LLC 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.

K051819C CHANGE SOLUTION WARMER

Related Devices (Code: LHC)

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.

K153713Getinge Series Warming CabinetGetinge Sourcing, LLCK152522ORS-3000LD Slush Drapes, ORS-1000LD Fluid Warming DrapesEcolab, Inc.K080609SWC/DWC WARMING CABINETSMac MedicalK051819C CHANGE SOLUTION WARMERC Change Surgical, LLCK0232831075LD HUSH-SLUSHO.R. Solutions, Inc.K023282ORS-3000LDO.R. Solutions, Inc.

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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