Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K961972
    Device Name
    MODEL AMI INFANT CENTRAL APHEA/HEART RATE MONITOR
    Manufacturer
    AEQUITRON MEDICAL, INC.
    Date Cleared
    1997-04-18

    (333 days)

    Product Code
    BZQ
    Regulation Number
    868.2375
    Why did this record match?
    Applicant Name (Manufacturer) :

    AEQUITRON MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Use of the Ami Infant Central ApnealHeart Rate Monitor is indicated for the continuous monitoring of an infant's heart rate and respiration rate in a home, hospital or portable environment. Continuous monitoring is indicated for infants whose physical condition may result or has resulted in an instability in heart rate or respiration which may become detrimental to the infant. Conditions which may require monitoring include (not all inclusive): Prematurity, Respiratory dysfunction, Neurologic dysfunction, Maternal drug abuse, Cardiovascular dysfunction.
    Device Description
    The Ami Infant Central ApnealHeart Rate Monitor is capable of monitoring an infant's respiratory and heart rates. The device utilizes respiration detection technology for respiratory effort detection and also detects ECG rate through the same two electrodes. The device also incorporates auxiliary inputs for recording stand-alone oximeter output parameters and/or other devices' signal outputs within specified parameters. The device operates off either battery of AC power.
    Ask a Question
    K Number
    K952880
    Device Name
    MODEL LP-1000 VOLUME VENTILATOR
    Manufacturer
    AEQUITRON MEDICAL, INC.
    Date Cleared
    1996-06-20

    (364 days)

    Product Code
    CBK
    Regulation Number
    868.5895
    Why did this record match?
    Applicant Name (Manufacturer) :

    AEQUITRON MEDICAL, INC.

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

    Page 1 of 1