BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇹 Italy

    DIDECO VACUUM PUMP

    K Number: K936220 · Decision Jan 27, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    53
    Registration Numbers
    53
    Same Product Code
    194
    Applicant Total
    5
    Review Days
    395

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    Basic Information

    Device Name
    DIDECO VACUUM PUMP
    K Number
    K936220
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5830
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Dideco
    Date Received
    December 28, 1993
    Decision Date
    January 27, 1995
    Product Code
    CAC
    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
    CAC Apparatus, Autotransfusion

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    Other Clearances by Dideco

    K Number Device Name
    K004001 MONOLYTH MIMESYS HOLLOW FIBER OXYGENATOR
    K010478 DIDECO D901 LILLIPUT HOLLOW FIBER OXYGENATOR WITH OR WITHOUT SOFT VENOUS RESERVOIR BAG, WITH BIOCOMPATABLE TREATMENT SUR
    K001388 DATA MASTER PERFUSION MONITORING SYSTEM
    K940519 DIDECO COMPACT-A AUTOTRANSFUSION SYSTEM