BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    MODEL 820 TOP=TRAK

    K Number: K873039 · Decision Feb 11, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    0
    Applicant Total
    12
    Review Days
    191

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    Basic Information

    Device Name
    MODEL 820 TOP=TRAK
    K Number
    K873039
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    868.5365
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Sierra Laboratories, Inc.
    Date Received
    August 4, 1987
    Decision Date
    February 11, 1988
    Product Code
    BYN
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    BYN Chair, Posture, For Cardiac And Pulmonary Treatment

    Other Clearances by Sierra Laboratories, Inc.

    K Number Device Name
    K970966 COMFORT CATH CHOICE MALE EXTERNAL CATHETER
    K962413 COMFORT CATH SPECIAL SELF ADHERING MALE EXTERNAL CATHETER
    K962384 COMFORT SHEATH REUSABLE MALE EXTERNAL CATHETER
    K934266 COMFORT CATH SELF ADHERING MALE EXTERNAL CATHETER
    K934052 ALPINE REUSABLE LEG BAGS
    K931156 CONE CATH
    K901000 URO TEX URINALS
    K883057 COMFORT CATH MALE EXTERNAL CATHETER
    K832450 URO-TEX MALE EXTERNAL CATHETER
    K811887 SKIN STAPLE EXTRACTOR
    Search all 12 clearances from Sierra Laboratories, Inc. →