BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    RECORDER, CHART, MODEL 5536

    K Number: K770342 · Decision Mar 1, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    52
    Registration Numbers
    52
    Same Product Code
    86
    Applicant Total
    33
    Review Days
    11

    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
    RECORDER, CHART, MODEL 5536
    K Number
    K770342
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    870.2810
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Hudson Oxygen Therapy Sales Co.
    Date Received
    February 18, 1977
    Decision Date
    March 1, 1977
    Product Code
    DSF
    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
    DSF Recorder, Paper Chart

    Similar 510(k) Clearances

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

    EDENTEC DIGITAL CHARTER MODEL 3710

    FDA 510(k)
    FDA Class 1 ·Cardiovascular

    DASH IV

    FDA 510(k)
    FDA Class 1 ·Cardiovascular

    MODEL 556 MONITOR

    FDA 510(k)
    FDA Class 1 ·Cardiovascular

    GRI LASERGRAPH(TM) ECG PAPER

    FDA 510(k)
    FDA Class 1 ·Cardiovascular

    COLORADO COLOR IMAGING RECORDER

    FDA 510(k)
    FDA Class 1 ·Cardiovascular

    GABRIEL MEDICAL CLS THERMAL RECORDER

    FDA 510(k)
    FDA Class 1 ·Cardiovascular
    View all

    Other Clearances by Hudson Oxygen Therapy Sales Co.

    K Number Device Name
    K902062 PEEP VALVE
    K900783 MDI ADAPTOR
    K900470 IN-THE NEBULIZER
    K895589 MANUAL RESUSCITATOR
    K896136 INFANT C.P.A.P. MONITOR
    K895231 CATALOG NO. 1755 1S0-NEB, A FILTERED NEBULIZER
    K895747 VENTILARM II PORTABLE AIRWAY PRESSURE MONITOR
    K890035 BACTERIA FILTER
    K870895 NO. 1552, VALVED VENTI-COMP
    K871157 C.P.A.P. NASAL CANNULA
    Search all 33 clearances from Hudson Oxygen Therapy Sales Co. →