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510(k) Data Aggregation
K Number
K103833Device Name
NEOPIP PATIENT CIRCUIT WITH PEEP
Manufacturer
NEOFORCE GROUP, INC.
Date Cleared
2011-04-20
(111 days)
Product Code
BYE
Regulation Number
868.5965Why did this record match?
Applicant Name (Manufacturer) :
NEOFORCE GROUP, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The NeoPIP™ Resuscitation Circuit with PEEP is indicated as an accessory to add positive end expiratory pressure breathing capability to a T-Piece Resuscitator. The PEEP valve is incorporated into the breathing circuit T-Piece with a standard fitting for face mask, laryngeal mask or endotracheal tube. The NeoPIP Resuscitation Circuit with PEEP is indicated for use in neonatal patients < 10Kg.
Device Description
The NeoPIP™ Resuscitation Circuit with PEEP control valve is a breathing circuit intended for use with manual resuscitation devices for emergency neonatal resuscitation.
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K Number
K102649Device Name
NEOPOP INFANT RESUSCITATOR WITH FLOW METER
Manufacturer
NEOFORCE GROUP, INC.
Date Cleared
2011-01-06
(114 days)
Product Code
BTM
Regulation Number
868.5915Why did this record match?
Applicant Name (Manufacturer) :
NEOFORCE GROUP, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The NeoPIP Infant Resuscitator with Flow Meter is a manually operated, gas powered device with integrated flow meter intended for controlled and accurate resuscitation of neonates and infants in the clinical environment.
Device Description
The NeoPIP Infant Resuscitator with Flow Meter is intended to deliver oxygen or blended gas to a neonate while controlling peak inspiratory pressure. Positive end expiratory pressure is controlled at the patient end of the breathing circuit. The device also provides a maximum pressure relief capability which is adjustable. The device is intended for emergency resuscitation and is manually operated.
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K Number
K092085Device Name
ISPIRA RESUSCITATION UNIT
Manufacturer
NEOFORCE GROUP, INC.
Date Cleared
2009-10-07
(90 days)
Product Code
BTL
Regulation Number
868.5925Why did this record match?
Applicant Name (Manufacturer) :
NEOFORCE GROUP, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The NeoForce ISPIRA Resuscitation System is a manually operated, gas powered resuscitator intended for controlled and accurate pulmonary resuscitation and emergency respiratory support of pediatric and adult patients with a body weight of more than 22 lbs (10 kg.) in the hospital, pre-hospital (EMS) and sub-acute / alternate site facility environments via face mask, laryngeal mask or endotracheal tube.
The device is also intended to provide CPAP to spontaneously breathing patients in the hospital, pre-hospital (EMS) and sub-acute / alternate site facility environments via face mask, laryngeal mask or endotracheal tube.
This is a prescription device.
Device Description
The ISPIRA Resuscitation System is intended to deliver a consistent tidal volume rescue breath of oxygen or blended gas to a pediatric or adult patient. Peak Inspiratory Pressure and flow are set by the user. The device also provides a maximum pressure relief capability which is adjustable. The device is intended for emergency resuscitation and is manually operated. In addition to resuscitation the device also provides CPAP capability.
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K Number
K072021Device Name
NEOPIP INFANT RESUSCITATOR
Manufacturer
NEOFORCE GROUP, INC.
Date Cleared
2007-09-12
(51 days)
Product Code
BTM
Regulation Number
868.5915Why did this record match?
Applicant Name (Manufacturer) :
NEOFORCE GROUP, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The NeoPIP Infant Resuscitation Unit is a manually operated, gas powered device intended for controlled and accurate resuscitation of neonates and infants in the clinical environment.
Device Description
The NeoPIP Infant Resuscitation Unit is intended to deliver oxygen or blended gas to a neonate while controlling peak inspiratory pressure. Positive end expiratory pressure is controlled at the patient end of the breathing circuit. The device also provides a maximum pressure relief capability which is adjustable. The device is intended for emergency resuscitation and is manually operated.
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K Number
K070416Device Name
NEOPEEP NEONATAL RESUSCITATION CIRCUIT WITH PEEP
Manufacturer
NEOFORCE GROUP, INC.
Date Cleared
2007-05-29
(106 days)
Product Code
BYE
Regulation Number
868.5965Why did this record match?
Applicant Name (Manufacturer) :
NEOFORCE GROUP, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The NeoPEEP Neonatal Resuscitation Circuit with PEEP valve is indicated as an accessory to add positive end expiratory pressure breathing capability to a Manual Resuscitator. This valve is designed into the breathing circuit T-Piece with a standard fitting for face mask, laryngeal mask or endotracheal tube attachment.
This is a prescription device.
Device Description
The NeoPEEP Neonatal Resuscitation Circuit with PEEP control valve is a breathing circuit intended for use with manual resuscitation devices for emergency neonatal resuscitation.
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K Number
K061280Device Name
V-2200 INFANT INCUBATOR
Manufacturer
NEOFORCE GROUP, INC.
Date Cleared
2006-06-27
(50 days)
Product Code
FMZ
Regulation Number
880.5400Why did this record match?
Applicant Name (Manufacturer) :
NEOFORCE GROUP, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The V-2200 Infant Incubator is a device to keep premature infants or neonatal infants in a warm environment which is covered by a hood and isolated from ambient air and of which internal air temperature and humidity, are controlled. It is intended for inpatient use in maternity nurseries, and neonatal care environments of hospitals or other healthcare facilities.
This device is not intended for home use.
This device is not intended as a transport incubator.
This is a prescription device.
Device Description
This product consists of a hood, a sensor module, a mattress platform, a middle deck section, a conditioning chamber, a humidity chamber, an operation control section, a power source, a relay box, an oxygen supply/filter box, an oxygen controller and a weight monitor. It is equipped with an incubator air temperature control function to circulate the air containing the heat energy generated by the heater attached to the conditioning chamber inside the hood by means of a fan in order to maintain the incubator air temperature at a fixed level. The device is also equipped with a skin temperature control function to maintain the infant's skin temperature at a fixed level in response to the patients temperature as measured by the skin probe. There is a humidity control function to adjust the amount of vapor generated in the humidity chamber. The following additional features can be installed into the incubator: an oxygen control function to draw oxygen and outside air and control the oxygen concentration delivered to the patient compartment to the desired level; and a weight monitor to facilitate taking the infants weight without moving them from the incubator. This device is designed to be used in treatment, procedures and observation of low-birth-weight and sick neonates, providing heat to the neonate when the body temperature is low and also to provide humidity if desired
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