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510(k) Data Aggregation
K Number
K982043Device Name
BRENEB
Manufacturer
BREMED ITALIA, S.R.L.
Date Cleared
1998-11-09
(152 days)
Product Code
CAF
Regulation Number
868.5630Why did this record match?
Applicant Name (Manufacturer) :
BREMED ITALIA, S.R.L.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This product is a hand held nebulizer that is used to provide aerosolized broncho dialator medication to persons with asthma or emphysema. The device creates aerosolized particles of the prescribed medication via interface with a nebulizer compressor.
Device Description
This product is a hand held nebulizer. The compressor creates air pressure which is forced up disposable tubing and into the hand held nebulizer. Inside the hand held nebulizer, the medication is forced via a vacuum created by the air pressure up into the baffle which mixes the medication with the air, creating the aerosolized particles. The patient inhales the aerosolized prescribed medication via a mouthpiece which is attached to the hand held nebulizer.
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K Number
K974379Device Name
ULTRANEB
Manufacturer
BREMED ITALIA, S.R.L.
Date Cleared
1998-02-18
(90 days)
Product Code
CAF
Regulation Number
868.5630Why did this record match?
Applicant Name (Manufacturer) :
BREMED ITALIA, S.R.L.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This product is an ultrasonic nebulizer that is used to provide acrosolized broncho dialator medication to persons with asthma and emphysema. The device creates acrosolized particles of the prescribed medication via ultrasound that is forced via a vacuum or draw into disposable tubing. The aerosolized medication travels up the lubing and into either a nasal or oral mask. The patient then inhales the medication as per his/her physician's orders.
Device Description
This product contains the exact same technological characteristics of similar devices currently on the market. The product functions exactly as these similar devices. The product is designed with similar performance characteristics as devices currently on the market. The performance of the device allows it to be used in conjunction with various nasal and oral masks that are currently in distribution in the United States and Europe. The components found within this product are common items. The product consists of a thermally protected, simplistic circuit board, a piczcoelectric ceramic, a medicine cup, an ABS plastic case, a switch, an electrical cord.
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K Number
K970542Device Name
MASTER NEB II
Manufacturer
BREMED ITALIA, S.R.L.
Date Cleared
1997-06-24
(132 days)
Product Code
CAF
Regulation Number
868.5630Why did this record match?
Applicant Name (Manufacturer) :
BREMED ITALIA, S.R.L.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This product is an air compressor that when used in conjunction with a hand held nebulizer, produces the nebulization of a liquid prescribed medication. The compressor produces an air source that is channeled through tubing into the hand held nebulizer. The nebulizer creates an aerosol mist by forcing the compressed air through the nebulizer baffle. This creates negative pressure in which the liquid medication is vacuumed into the air, creating the aerosol mist.
Device Description
This product contains the exact same technological characteristics of similar devices currently on the market. The product functions exactly as these similar devices.
The product is designed with similar performance characteristics as devices currently on the market. The performance of the device allows it to be used in conjunction with various hand held nebulizers that are currently in distribution in the United States and Europe.
The components found within this product are common items. The product consists of a thermally protected motor, a cylinder and piston assembly (the compressor) attached to the motor, the case, a switch, an electrical cord, and a printed circuit board. The circuit board makes the wiring more stable and organized, thus ensuring higher quality and safety.
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