BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    PENLON AM1000 ANAESTHESIA MACHINE

    K Number: K844008 · Decision Mar 12, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33
    Same Product Code
    187
    Applicant Total
    10
    Review Days
    151

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    Basic Information

    Device Name
    PENLON AM1000 ANAESTHESIA MACHINE
    K Number
    K844008
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5160
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Penlon, Inc.
    Date Received
    October 12, 1984
    Decision Date
    March 12, 1985
    Product Code
    BSZ
    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
    BSZ Gas-Machine, Anesthesia

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    Other Clearances by Penlon, Inc.

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    K844007 PENLON PPV VAPORIZER
    K823555 MAGTARAK RESPIRATORY MONITOR & FLOW SENS
    K803052 NUFFIELD ANESTHESIA VENTILATOR SER. 400
    K801253 CREST ELECTRONIC WARMING BLANKET
    K801254 PENLON I.D.P. PRESSSURE FAILURE ALARM
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