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

    PCX-100 PATIENT INPUT LEADWIRE

    K Number: K851632 · Decision Nov 8, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    7
    Applicant Total
    15
    Review Days
    204

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    Basic Information

    Device Name
    PCX-100 PATIENT INPUT LEADWIRE
    K Number
    K851632
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2350
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Eaton Medical Group
    Date Received
    April 18, 1985
    Decision Date
    November 8, 1985
    Product Code
    DRW
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DRW Adaptor, Lead Switching, Electrocardiograph

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    Other Clearances by Eaton Medical Group

    K Number Device Name
    K851623 MODEL TRC-40 TELEMETRY RECIEVER MODULE
    K851624 MODEL TT-185 TELEMETRY TRANSMITTER
    K851625 SCX-10 SINGLE CHANNEL RECORDER ACCESS. FOR G-2000
    K851627 KBX-20 OUTBOARD KEYBOARD ACCESS. FOR G-2000 ELECTR
    K851631 TMX-C1/C2 TRADMILL CONTROLLER ACCESS.
    K851630 TMX-80 TREADMILL
    K851629 TMX-70 TREADMILL
    K851628 RMG-9 9 REMOTE MONITOR ACCESS. FOR G-2000 ELECTRO
    K851626 SCX-35 THREE CHANNEL ACCESS. FOR MODULE G-2000 ELE
    K851633 CC-100 CLOCK/CALANDER MODULE ACCESS. FOR G-2000 EL
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