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

    MICRO-TEMP PUMPS & MICRO-TEMP PADS

    K Number: K843146 · Decision Aug 17, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    123
    Registration Numbers
    123
    Same Product Code
    92
    Applicant Total
    12
    Review Days
    7

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    MICRO-TEMP PUMPS & MICRO-TEMP PADS
    K Number
    K843146
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5720
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Seabrook Medical Systems, Inc.
    Date Received
    August 10, 1984
    Decision Date
    August 17, 1984
    Product Code
    ILO
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    PM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    ILO Pack, Hot Or Cold, Water Circulating

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (ILO), ordered by most recent decision date.

    Armory Motion

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    COOLSKIN

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    T-PUMP LOCALIZED TEMPERATURE THERAPY PUMP

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    JUNIPER CLN1 DERMAL COOLING DEVICE

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    MODIFICATION TO POLAR CARE 500

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    IVC SYSTEM

    FDA 510(k)
    FDA Class 2 ·Physical Medicine
    View all

    Other Clearances by Seabrook Medical Systems, Inc.

    K Number Device Name
    K946196 TROPICAIR CONVECTIVE WARING SYSTEM
    K952086 TROPICAIR CONVECTIVE WARMING BLANKETS
    K931203 COOL-AID
    K923104 TROPIC-AIR
    K914182 GOLDEN THERMAL(R)
    K902756 TROPI-COOL
    K902269 ELECTRI-COOL(TM) LIQUID-CIRCULAT. THERMAL THERAPY
    K902268 PEDIA-TEMP(TM) LIQUID-CIRCULATING HYPO-HYPERTHERM.
    K882310 DUAL-TEMP(TM) COOLING/WARMING UNIT
    K881322 MINI-TEMP(TM)
    Search all 12 clearances from Seabrook Medical Systems, Inc. →