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510(k) Data Aggregation
K Number
K032809Device Name
HOSPITAL SPACER
Manufacturer
RESPIRONICS HEALTHSCAN, INC.
Date Cleared
2003-11-13
(65 days)
Product Code
CAF
Regulation Number
868.5630Why did this record match?
Applicant Name (Manufacturer) :
RESPIRONICS HEALTHSCAN, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ProChamber™ Valved Holding Chamber is intended for use in combination with Metered Dose Inhalers (MDI's) to assist in respiratory drug delivery. All patients using MDI's, i.e., children and adults, may use ProChamber ™. Settings for use include the home, clinics and hospitals.
This device is intended for prescription use.
Device Description
The device consists of an MDI Adapter, a Chamber, a Mouthpiece, a Duckbill Valve, an Exhaust Valve and a Silicone Cap. There are no electrical or electronic components.
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K Number
K013027Device Name
MISTER NEB NEBULIZER COMPRESSOR, WITH NEBULIZER, MODEL HS123
Manufacturer
RESPIRONICS HEALTHSCAN, INC.
Date Cleared
2001-12-06
(87 days)
Product Code
BTI
Regulation Number
868.6250Why did this record match?
Applicant Name (Manufacturer) :
RESPIRONICS HEALTHSCAN, 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, COPD, etc.
Device Description
This line-powered piston compressor is housed in a plastic cabinet (case). Dimensions are 7.3 in. x 6.9 in. x 4.0 in. and weighs 3.3 lbs. It consists of a motor-driven piston compressor, an in-line fuse, and a switch; it contains no microprocessors or other electronic components. It operates from 115 VAC, 60 Hz. It is supplied with tubing, an instruction manual, and a 510(k) cleared nebulizer.
In use, the compressor is placed on a flat surface and the nebulizer tubing is connected to the hose barb. The unit is then turned on. Inlet air to the compressor passes through a replaceable filter.
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