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Found 14 results
510(k) Data Aggregation
K Number
K051529Device Name
AMBU NEUROLINE GROUND
Manufacturer
AMBU, INC.
Date Cleared
2005-08-04
(56 days)
Product Code
GXY
Regulation Number
882.1320Why 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
K042682Device Name
AMBU SPUR II. ADULT SINGLE PATIENT RESUSCITATOR
Manufacturer
AMBU, INC.
Date Cleared
2004-11-15
(47 days)
Product Code
BTM
Regulation Number
868.5915Why 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
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K Number
K042843Device 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
868.5915Why 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
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K Number
K041734Device Name
AMBU DISPOSABLE ECG ELECTRODE
Manufacturer
AMBU, INC.
Date Cleared
2004-09-22
(89 days)
Product Code
DRX
Regulation Number
870.2360Why 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
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K Number
K040991Device Name
AMBU DISPOSABLE PRESSURE MANOMETER
Manufacturer
AMBU, INC.
Date Cleared
2004-07-22
(97 days)
Product Code
CAP
Regulation Number
868.2600Why 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
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K Number
K041026Device 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
870.2360Why 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
K032278Device Name
AMBU NEUROLINE SINGLE PATIENT EEG/EP CUP ELECTRODE
Manufacturer
AMBU, INC.
Date Cleared
2004-03-05
(225 days)
Product Code
GXY
Regulation Number
882.1320Why 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
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K Number
K032421Device Name
AMBU PEDIATRIC MULTI-FUNCTION DEFIBRILLATION ELECTRODE
Manufacturer
AMBU, INC.
Date Cleared
2004-02-27
(206 days)
Product Code
MKJ
Regulation Number
870.5310Why 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
K010583Device Name
AMBU GEL, HYDROGEL BURN DRESSING
Manufacturer
AMBU, INC.
Date Cleared
2001-05-25
(87 days)
Product Code
MGQ
Regulation Number
N/AWhy 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
K993278Device Name
AMBU NEONATE SILICONE RESUSCITATOR
Manufacturer
AMBU, INC.
Date Cleared
2000-05-17
(230 days)
Product Code
BTM
Regulation Number
868.5915Why 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
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