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

    PE ELECTROPHYSIOLOGY LAB SYSTEM (PEEP)

    K Number: K902716 · Decision Sep 4, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    178
    Registration Numbers
    178
    Same Product Code
    429
    Applicant Total
    6
    Review Days
    76

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    Basic Information

    Device Name
    PE ELECTROPHYSIOLOGY LAB SYSTEM (PEEP)
    K Number
    K902716
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1425
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Prucka Engineering, Inc.
    Date Received
    June 20, 1990
    Decision Date
    September 4, 1990
    Product Code
    DQK
    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
    DQK Computer, Diagnostic, Programmable

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    Other Clearances by Prucka Engineering, Inc.

    K Number Device Name
    K993414 PRUCKA ENGINEERING INC. CARDIOLAB EP SYSTEM,VERSION 4.2
    K960321 CARDIOCATH CATHETERIZATION LAB SYSTEM
    K904747 PEI PLAQUE ELECTRODE ARRAY
    K910307 CARDIOLAB AMPLIFIER MODULE (CAM)
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