BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Thermogard HQ™ Temperature Management System, Thermogard XP® Temperature Management System

    K Number: K231182 · Decision Nov 3, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    5
    Applicant Total
    8
    Review Days
    191

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    Basic Information

    Device Name
    Thermogard HQ™ Temperature Management System, Thermogard XP® Temperature Management System
    K Number
    K231182
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5900
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Zoll Circulation, Inc.
    Date Received
    April 26, 2023
    Decision Date
    November 3, 2023
    Product Code
    NZE
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    NZE Hyperthermia Monitor

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    Other Clearances by Zoll Circulation, Inc.

    K Number Device Name
    K250979 Thermogard HQ™ Temperature Management System, Thermogard XP® Temperature Management System (VitalTemp™ Universal Pad)
    K221700 AutoPulse NXT Resuscitation System
    K223746 Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Thermogard XP Console, Thermogard HQ Console
    K220008 Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Thermogard HQ Start-Up Kit, Thermogard HQ Start-Up Kit EX, Thermogard HQ Console
    K213031 Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Start-Up Kit, Coolgard 3000 Console, Thermogard XP Console
    K153226 Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up Kit
    K150046 Start-Up Kit (SUK), Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter