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

    SENTRY INSERTION TRAY

    K Number: K942827 · Decision Nov 2, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    16
    Registration Numbers
    17
    Same Product Code
    33
    Applicant Total
    13
    Review Days
    141

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    Basic Information

    Device Name
    SENTRY INSERTION TRAY
    K Number
    K942827
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5200
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Sentry Medical Products, Inc.
    Date Received
    June 14, 1994
    Decision Date
    November 2, 1994
    Product Code
    FOS
    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
    FOS Catheter, Umbilical Artery

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    Other Clearances by Sentry Medical Products, Inc.

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    K935098 BABY BOARD
    K933603 LEADWIRE
    K932704 PATIENT CABLE
    K881670 ACCUTEMP PLUS
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    K851522 DIAGNOSTIC ECG DISPOSABLE ELECTRODE
    K853552 SENTRY FLEXIBLE TENS
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