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FDA 510(k)

UROSURGE UROTHERM FLUID WARMING SYSTEM

K-Number: K965136 · 1998-10-16

ApplicantPrinceton Regulatory Assoc.
Decision Date1998-10-16
Product CodeLHC
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

UROSURGE UROTHERM FLUID WARMING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Princeton Regulatory Assoc.. It received FDA 510(k) clearance on 1998-10-16 under 510(k) number K965136. 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 UROSURGE UROTHERM FLUID WARMING SYSTEM?

UROSURGE UROTHERM FLUID WARMING SYSTEM is a medical device that received FDA 510(k) clearance on 1998-10-16. The listed applicant is Princeton Regulatory Assoc.. The 510(k) number is K965136.

When did UROSURGE UROTHERM FLUID WARMING SYSTEM receive FDA 510(k) clearance?

UROSURGE UROTHERM FLUID WARMING SYSTEM received FDA 510(k) clearance on 1998-10-16, under 510(k) number K965136.

Who is the listed applicant for UROSURGE UROTHERM FLUID WARMING SYSTEM?

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

What is the FDA product code for UROSURGE UROTHERM FLUID WARMING SYSTEM?

The FDA product code for UROSURGE UROTHERM FLUID WARMING SYSTEM 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.

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Other records listing Princeton Regulatory Assoc. 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.

K972158GO MEDICAL PATIENT CONTROLLED ANALGESIA DEVICESK973504UROSURGE UROSTENTK962770UROSURGE ACUTRAINER

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.K083417INTRATEMP SOLUTION WARMERC Change Surgical, LLCK080609SWC/DWC WARMING CABINETSMac MedicalK051819C CHANGE SOLUTION WARMERC Change Surgical, LLCK023282ORS-3000LDO.R. Solutions, Inc.

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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