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510(k) Data Aggregation
K Number
K970035Device Name
JOHN BUNN NEB-U-LITE II MEDICATION COMPRESSOR WITH DISPOSABLE NEBULIZER, MODEL #JBO-112-009
Manufacturer
GRAHAM-FIELD, INC.
Date Cleared
1997-04-01
(88 days)
Product Code
CAF
Regulation Number
868.5630Why did this record match?
Applicant Name (Manufacturer) :
GRAHAM-FIELD, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This nebulizer compressor is an AC-powered air compressor intended to provide a source of compressed air for medical purposes for use in home health care. This device is used in conjunction with a pneumatic nebulizer to produce a fine aerosol mist of medication for respiratory therapy, for both children and adults suffering from respiratory disorders such as asthma, allergies, etc.
Device Description
This piston-driven nebulizer contains vents in the two sides and bottom of the case providing ventilation for the motor. The compressor has only one control a double pole toggle switch to turn the compressor on and off. The unit has a two-wire power cord with polarized plug, an internal fuse, and no exposed metal that is likely to become energized (two screws that hold the case together are greatly recessed on the bottom surface and are not likely to become energized). In use, the compressor is placed on a flat surface and the cover is opened to reveal an outlet hose barb to which the oxygen (air) delivery tubing and nebulizer are connected. Inlet air to the compressor passes through a replaceable filter.
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K Number
K961857Device Name
LABTRON ELECTROMAX ELECTRONIC STETHOSCOPE MODEL NO. 04-1060
Manufacturer
GRAHAM-FIELD, INC.
Date Cleared
1996-07-03
(50 days)
Product Code
DQD
Regulation Number
870.1875Why did this record match?
Applicant Name (Manufacturer) :
GRAHAM-FIELD, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For projecting the sounds associated with the heart, arteries, veins and other internal organs, using the principles of electronic amplification to enhance the acoustical sounds of the device.
Device Description
This electronic stethoscope electronically amplifies sound with fingertip control; it is turned on by pressing and holding a button on the back of the diaphragm housing. The stethoscope has a volume control and a two position frequency response switch.
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