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

    TECNOL TELEMETRY UNIT POUCH

    K Number: K802849 · Decision Dec 16, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    125
    Registration Numbers
    125
    Same Product Code
    190
    Applicant Total
    35
    Review Days
    34

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    Basic Information

    Device Name
    TECNOL TELEMETRY UNIT POUCH
    K Number
    K802849
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2910
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Tecnol New Jersey Wound Care, Inc.
    Date Received
    November 12, 1980
    Decision Date
    December 16, 1980
    Product Code
    DRG
    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
    DRG Transmitters And Receivers, Physiological Signal, Radiofrequency

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    Other Clearances by Tecnol New Jersey Wound Care, Inc.

    K Number Device Name
    K913043 MODIFICATION TECNOL FLUIDSHIELD SURGICAL MASKS
    K911891 FLUIDSHIELD(TM) CONE CLASSIC(TM) II SURGICAL MASK
    K911907 FLUIDSHIELD CONE CLASSIC II SURG MASK W/SPLASH VIS
    K896193 TECNOL LAZER(TM) SURGICAL MASK
    K894205 TECNOL SILK STRIP
    K893702 TECNOL GAITERS PRODUCT NUMBER 47725-010
    K891187 TECNOL NASO-GASTRIC TUBE HOLDER
    K891178 TECNOL SECURE-ALL TUBE HOLDER
    K884440 TECNOL VARIABLE TENSION BANDAGE
    K882640 TECNOL SECURE-ALL PELVIC TRACTION BELT
    Search all 35 clearances from Tecnol New Jersey Wound Care, Inc. →