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510(k) Data Aggregation

    K Number
    K011597
    Device Name
    SMARTMONITOR 2, MODEL 4000
    Manufacturer
    RESPIRONICS GEORGIA, INC.
    Date Cleared
    2002-01-11

    (232 days)

    Product Code
    FLS
    Regulation Number
    868.2377
    Why did this record match?
    Applicant Name (Manufacturer) :

    RESPIRONICS GEORGIA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SmartMonitor® 2 Infant Apnea Monitor is intended for use in the continuous monitoring of respiration and heart rate of infant patients in a home or hospital environment. The monitor detects and alarms for periods of central apnea and high or low heart rates.
    Device Description
    The SmartMonitor 2 is a monitoring device designed to monitor respiration and heart rate. Upon detection of abnormal events, SmartMonitor 2 alerts the caregiver via both visual and audible alarms and records the information for subsequent clinical review. SmartMonitor 2 acquires the electrical activity of the heart via a two or three-lead electrode configuration. The same set of electrodes is used to measure transthoracic impedance and to subsequently develop a respiration signal. Detection of heart beats and respiration breaths is accomplished via softwarebased algorithms, which analyze the ECG and respiration signals. When beats or breaths are detected, SmartMonitor 2 provides feedback by blinking the Heart and Respiration LED's and calculates apnea intervals, average heart rates, and average breath rates for the purpose for identifying ECG and respiration rates that violate preset threshold values. In addition to the alarms, when abnormal ECG and respiration rates are detected, both tabular data and associated waveforms are logged in nonvolatile memory for subsequent review by a Health Care Professional.
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    K Number
    K001708
    Device Name
    PROFOX SOFTWARE, MODEL 920M-41
    Manufacturer
    RESPIRONICS GEORGIA, INC.
    Date Cleared
    2001-03-01

    (269 days)

    Product Code
    DQA
    Regulation Number
    870.2700
    Why did this record match?
    Applicant Name (Manufacturer) :

    RESPIRONICS GEORGIA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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