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510(k) Data Aggregation

    K Number
    K010156
    Device Name
    SLEEP PAT 200 DEVICE
    Manufacturer
    ITAMAR MEDICAL (C.M.) 1997 LTD.
    Date Cleared
    2002-06-19

    (519 days)

    Product Code
    MNR
    Regulation Number
    868.2375
    Why did this record match?
    Applicant Name (Manufacturer) :

    ITAMAR MEDICAL (C.M.) 1997 LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K010739
    Device Name
    WATCH-PAT 100
    Manufacturer
    ITAMAR MEDICAL (C.M.) 1997 LTD.
    Date Cleared
    2001-11-06

    (239 days)

    Product Code
    MNR
    Regulation Number
    868.2375
    Why did this record match?
    Applicant Name (Manufacturer) :

    ITAMAR MEDICAL (C.M.) 1997 LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K001852
    Device Name
    PERIPHERAL ARTERIAL TONOMETER-PAT 1000RD DEVICE
    Manufacturer
    ITAMAR MEDICAL (C.M.) 1997 LTD.
    Date Cleared
    2001-02-21

    (247 days)

    Product Code
    DQK
    Regulation Number
    870.1425
    Why did this record match?
    Applicant Name (Manufacturer) :

    ITAMAR MEDICAL (C.M.) 1997 LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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