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

    H.R. JAKOBI SURG. INSTRUMENTS #9 48

    K Number: K834179 · Decision Jan 27, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    74
    Registration Numbers
    74
    Same Product Code
    127
    Applicant Total
    52
    Review Days
    67

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    Basic Information

    Device Name
    H.R. JAKOBI SURG. INSTRUMENTS #9 48
    K Number
    K834179
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5800
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Imm Enterprises , Ltd.
    Date Received
    November 21, 1983
    Decision Date
    January 27, 1984
    Product Code
    BTO
    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
    BTO Tube, Tracheostomy (W/Wo Connector)

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    Other Clearances by Imm Enterprises , Ltd.

    K Number Device Name
    K840311 CAT. 7-EAR, NOSE & THROAT DEVICES
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    K841386 KOLLMANN URETHRAL DILATOR
    K840304 CATEGORY 17-MICROBIOLOGY DEVICES
    K840318 CAT. 14-CLINICAL TOXIOLOGY DEVICES
    K840305 CATEGORY 1 CIRCULATORY SYSTEM DEVICE
    K840312 CAT. 8 DENTAL DEVICES
    K834171 OP-CON SURG. INSTRUMENT #3
    K834191 JAKOBI SURGICAL INSTRUMENTS #3 17/18/19
    K834192 JAKOBI SURG. INSTRUMENTS #3 21/22/24
    Search all 52 clearances from Imm Enterprises , Ltd. →