BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇱 Israel

    PERIPHERAL ARTERIAL TONOMETER-PAT 1000RD DEVICE

    K Number: K001852 · Decision Feb 21, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    178
    Registration Numbers
    178
    Same Product Code
    429
    Applicant Total
    3
    Review Days
    247

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    Basic Information

    Device Name
    PERIPHERAL ARTERIAL TONOMETER-PAT 1000RD DEVICE
    K Number
    K001852
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1425
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Itamar Medical (C.M.) 1997 , Ltd.
    Date Received
    June 19, 2000
    Decision Date
    February 21, 2001
    Product Code
    DQK
    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
    DQK Computer, Diagnostic, Programmable

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    Other Clearances by Itamar Medical (C.M.) 1997 , Ltd.

    K Number Device Name
    K010156 SLEEP PAT 200 DEVICE
    K010739 WATCH-PAT 100