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510(k) Data Aggregation

    K Number
    K051529
    Device Name
    AMBU NEUROLINE GROUND
    Manufacturer
    AMBU, INC.
    Date Cleared
    2005-08-04

    (56 days)

    Product Code
    GXY
    Regulation Number
    882.1320
    Why did this record match?
    Applicant Name (Manufacturer) :

    AMBU, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of Ambu Neuroline Ground electrode is to ensure the presence of the same electrical potential at the amplifier and the measuring point during a neurophysiological examination of muscles and/or nerves. The electrode is for single patient use only.
    Device Description
    Ambu Neuroline Ground electrode should only be used by or on the order of a physician. Ambu Neuroline Ground electrode is used to ensure the presence of the same electrical potential at the amplifier and the measuring point during a neurophysiological examination. Ambu Neuroline Ground electrode is provided non-sterile. Ambu Neuroline Ground electrode is a single patient use disposable device. Ambu Neuroline Ground electrode is a multi-layer construction containing a hydrogel, a conductive film and a lead wire.
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    K Number
    K042682
    Device Name
    AMBU SPUR II. ADULT SINGLE PATIENT RESUSCITATOR
    Manufacturer
    AMBU, INC.
    Date Cleared
    2004-11-15

    (47 days)

    Product Code
    BTM
    Regulation Number
    868.5915
    Why did this record match?
    Applicant Name (Manufacturer) :

    AMBU, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ambu SPUR II Adult Single Patient Use Resuscitator is intended for pulmonary resuscitation and emergency respiratory support of adult patients with a body weight of more than 66lbs (30kg).
    Device Description
    Not Found
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    K Number
    K042843
    Device Name
    AMBU SPUR II INFANT AND PEDIATRIC SINGLE PATIENT USE RESUSCITATORS
    Manufacturer
    AMBU, INC.
    Date Cleared
    2004-11-12

    (29 days)

    Product Code
    BTM
    Regulation Number
    868.5915
    Why did this record match?
    Applicant Name (Manufacturer) :

    AMBU, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ambu SPUR II Infant Single Patient Use Resuscitator is intended for pulmonary resuscitation and emergency respiratory support of neonates and infants with a body weight up to 22lbs (10kg). The Ambu SPUR II Pediatric Single Patient Use Resuscitator is intended for pulmonary resuscitation and emergency respiratory support of infants and children with a body weight up to 66lbs (30kg), approx. 9 years of age.
    Device Description
    Not Found
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    K Number
    K041734
    Device Name
    AMBU DISPOSABLE ECG ELECTRODE
    Manufacturer
    AMBU, INC.
    Date Cleared
    2004-09-22

    (89 days)

    Product Code
    DRX
    Regulation Number
    870.2360
    Why did this record match?
    Applicant Name (Manufacturer) :

    AMBU, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Ambu General Purpose Disposable ECG Electrodes are intended for use in all Standard ECG Applications. Electrodes are made for single patient use only.
    Device Description
    Not Found
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    K Number
    K040991
    Device Name
    AMBU DISPOSABLE PRESSURE MANOMETER
    Manufacturer
    AMBU, INC.
    Date Cleared
    2004-07-22

    (97 days)

    Product Code
    CAP
    Regulation Number
    868.2600
    Why did this record match?
    Applicant Name (Manufacturer) :

    AMBU, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Ambu Disposable Pressure Manometer will be used to provide visual indication of the patient's airway pressure and may be attached to the manometer port on venting bags, hyperinflation bags, CPAP Mask or CPAP Circuits.
    Device Description
    Not Found
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    K Number
    K041026
    Device Name
    AMBU BLUE SENSOR, MRX, ECG ELECTRODE PRODUCT #:MRX-00-S
    Manufacturer
    AMBU, INC.
    Date Cleared
    2004-06-28

    (68 days)

    Product Code
    DRX
    Regulation Number
    870.2360
    Why did this record match?
    Applicant Name (Manufacturer) :

    AMBU, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ambu® Blue Sensor MRX electrode is applied to the surface of the body to transmit the electrical signal at the body surface to a processor in order to produce an electrocardiogram or vectorcardiogram. The electrode is designed for use in MR environment, therefore the electrode is MR safe, and for X-ray purposes, therefore the electrode is x-ray translucent. The electrode is for single patient use only.
    Device Description
    Each electrode consists of a foam material with an adhesive to be mounted on the patient. The sensor element consists of a foil furnished with a conductive carbon filled polymer snap and a Ag/AgCl sensor point. On top of the sensor point a sponge is positioned filled with a wet gel that conducts the signal from the patient further on to the electrode. The choise of materials ensures a non-ferromagnetic electrode which makes it x-ray translucent and MR safe. The electrodes are delivered on a foil sheet with 8 electrodes and 32 electrodes are packed in a laminated foil pouch. The electrode is non sterile and intended for single use.
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    K Number
    K032278
    Device Name
    AMBU NEUROLINE SINGLE PATIENT EEG/EP CUP ELECTRODE
    Manufacturer
    AMBU, INC.
    Date Cleared
    2004-03-05

    (225 days)

    Product Code
    GXY
    Regulation Number
    882.1320
    Why did this record match?
    Applicant Name (Manufacturer) :

    AMBU, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Single Patient EEG/EP Cup Electrode is intended for use with recording, monitoring and stimulation equipment for the purpose of recording of biopotential signals for example: Electroencephalograph (EEG) and Nerve potentials signals. The electrodes are for single patient use only.
    Device Description
    Not Found
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    K Number
    K032421
    Device Name
    AMBU PEDIATRIC MULTI-FUNCTION DEFIBRILLATION ELECTRODE
    Manufacturer
    AMBU, INC.
    Date Cleared
    2004-02-27

    (206 days)

    Product Code
    MKJ
    Regulation Number
    870.5310
    Why did this record match?
    Applicant Name (Manufacturer) :

    AMBU, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Ambu Paediatic Multi-Function Defibrillation Electrodes are used for defibrillation, pacing, monitoring ECG applications and synchronized cardioversion. The Paediatic Multi-Function Defibrillation Electrodes may be used with Class III type of external defibrillators (automated external defibrillators) or class II type of transcutaneous external pacemakers (pulse amplitude not to exceed 200mA in pulse duration not to exceed 200 m sec. The electrode can be used with mono- and biphasic defibriliators. The electrode is intended for use on pediatric patients whose weight is less than 10kg (22lbs). Disposable electrode, for single use, only, The electrode is intended for use on defibrillators who's output is maximum 100 Joule. Individual catalogue numbers are labeled for specific use primarily based on the interface connector and cable system which defines the host external device.
    Device Description
    Not Found
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    K Number
    K010583
    Device Name
    AMBU GEL, HYDROGEL BURN DRESSING
    Manufacturer
    AMBU, INC.
    Date Cleared
    2001-05-25

    (87 days)

    Product Code
    MGQ
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    AMBU, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K993278
    Device Name
    AMBU NEONATE SILICONE RESUSCITATOR
    Manufacturer
    AMBU, INC.
    Date Cleared
    2000-05-17

    (230 days)

    Product Code
    BTM
    Regulation Number
    868.5915
    Why did this record match?
    Applicant Name (Manufacturer) :

    AMBU, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ambu Neonate Sillcone Resuscitator is intended for ventilation of neonates and infants with a body weight up to 22 lb (10 kg).
    Device Description
    Not Found
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