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

    PALCO LABS MODEL 300 OXYGEN/PULSE MONITOR

    K Number: K911191 · Decision Jun 10, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    400
    Registration Numbers
    400
    Same Product Code
    725
    Applicant Total
    9
    Review Days
    84

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    Basic Information

    Device Name
    PALCO LABS MODEL 300 OXYGEN/PULSE MONITOR
    K Number
    K911191
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2700
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Palco Laboratories, Inc.
    Date Received
    March 18, 1991
    Decision Date
    June 10, 1991
    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 Palco Laboratories, Inc.

    K Number Device Name
    K942810 PALCO LABS COLD POUCH
    K943842 PULSE OXIMETER MODEL 305
    K920066 PALCO LABS MODEL 340 PULSE OXIMETER
    K913694 PALCO LABS LOADMATIC
    K904988 PALCO LABS MODEL 400 OXYGEN/PULSE MONITOR
    K872233 INJECT-EASE
    K842547 WET-STOP
    K833344 AUTO-LANCET