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

    DELWA-STAR PACIFIER THERMOMETER

    K Number: K952765 · Decision Oct 13, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    488
    Registration Numbers
    488
    Same Product Code
    797
    Applicant Total
    3
    Review Days
    162

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    Basic Information

    Device Name
    DELWA-STAR PACIFIER THERMOMETER
    K Number
    K952765
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2910
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Zewa, Inc.
    Date Received
    May 4, 1995
    Decision Date
    October 13, 1995
    Product Code
    FLL
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FLL Continuous Measurement Thermometer

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    Other Clearances by Zewa, Inc.

    K Number Device Name
    K041491 ZEWA MFM-007 BLOOD PRESSURE MONITOR
    K024077 DELWA-STAR WS-FM BLOOD PRESSURE AND BODY FAT MONITOR