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

    CONTINUOUS EPIDURAL ANESTHESIA TRAY/DRUG

    K Number: K802065 · Decision Sep 9, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    55
    Registration Numbers
    55
    Same Product Code
    74
    Applicant Total
    20
    Review Days
    13

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    Basic Information

    Device Name
    CONTINUOUS EPIDURAL ANESTHESIA TRAY/DRUG
    K Number
    K802065
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5120
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Portex, Inc.
    Date Received
    August 27, 1980
    Decision Date
    September 9, 1980
    Product Code
    BSO
    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
    BSO Catheter, Conduction, Anesthetic

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    Other Clearances by Portex, Inc.

    K Number Device Name
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    K023793 1ST RESPONSE INTERMEDIATE MANUAL RESUSCITATOR
    K014115 1ST RESPONSE MANUAL RESUSCITATOR, MODEL 85XX
    K014073 HYPODERMIC NEEDLE-PRO INSULIN SYRINE & NEEDLE WITH NEEDLE PROTECTION DEVICE
    K873992 LARYNGECTOMY TUBE
    K874597 THERMOVENT 600, 1200, T, 02
    K862167 MINI-TRACH KIT
    K842456 JET VENTILATION ADAPTOR
    K833908 IRRI-CATH
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