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

    COBE AEPS

    K Number: K842054 · Decision Aug 2, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    13
    Applicant Total
    77
    Review Days
    72

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    COBE AEPS
    K Number
    K842054
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4205
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Cobe Laboratories, Inc.
    Date Received
    May 22, 1984
    Decision Date
    August 2, 1984
    Product Code
    KRL
    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
    KRL Detector, Bubble, Cardiopulmonary Bypass

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (KRL), ordered by most recent decision date.

    STOCKERT AIR PURGE CONTROL SYSTEM MODEL 23-45-05

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CAPIOX BUBBLE TRAP WITH X-COATING

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    EDAC QUANTIFIER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    AUTOMATIC TUBING CLAMP SYSTEM (ATC)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ELS AUTOMATIC TUBING CLAMP SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SARNS ULTRASONIC AIR SENSOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular
    View all

    Other Clearances by Cobe Laboratories, Inc.

    K Number Device Name
    K923272 COBE CMS-HF HOLLOW FIBER MEMBRANE OXYGENATOR
    K900105 COBE SPECTRA BLOOD COMPONENT SEPARATOR THERAPEUTIC
    K905793 COBE CENTRY 2 BICART OPTION KIT
    K905388 COBE CENTRYSYSTEM 3 BICART OPTION KIT
    K904336 NEW COBE SATURATION/HEMATOCRIT MONITOR
    K902631 COBE ICU CONVERSION KIT
    K902437 COBE CARDIOTOMY RESERVOIR WITH OR WITHOUT FILTER
    K904566 NEW COBE CENTRYSYSTEM(TM) 100 HG DIALYZER
    K902758 COBE SATURATION/HEMATOCRIT MONITOR W/ FIBER OPTIC
    K902759 COBE CLOSED WOUND DRAINAGE KIT
    Search all 77 clearances from Cobe Laboratories, Inc. →