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

    INDEX SPO2 SIMULATOR

    K Number: K933519 · Decision Sep 1, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    400
    Registration Numbers
    400
    Same Product Code
    725
    Applicant Total
    37
    Review Days
    408

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    Basic Information

    Device Name
    INDEX SPO2 SIMULATOR
    K Number
    K933519
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2700
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Bio-Tek Instruments, Inc.
    Date Received
    July 20, 1993
    Decision Date
    September 1, 1994
    Product Code
    DQA
    Advisory Committee
    Cardiovascular
    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
    DQA Oximeter

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    Other Clearances by Bio-Tek Instruments, Inc.

    K Number Device Name
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    K961862 MODELS IDA-2 PLUS AND IPT-1
    K954391 MODELS QED-6, 6M AND 6H DEFIBRILLATOR ANALYZER WITH OPTIONAL UNIVERSAL PACEMAKER LOAD ADAPTER
    K953710 ELX808 AUTOMATED MICROPLATE READERS
    K953572 ELX800UV
    K950104 ELX800 AND EL800 AUTOMATED MICROPLATE READERS
    K942923 CERES 900C & CERES UV900C
    K944257 LIONHEART 3 MULTI-PARAMETER SIMULATOR
    K933548 ELS 1000
    Search all 37 clearances from Bio-Tek Instruments, Inc. →