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510(k) Data Aggregation
K Number
K121770Device Name
HEADSTAR MEDICAL SMALL VOLUME JET NEBULIZER
Manufacturer
HEADSTAR MEDICAL PRODUCTS CO., LTD
Date Cleared
2013-04-17
(306 days)
Product Code
CAF
Regulation Number
868.5630Why did this record match?
Applicant Name (Manufacturer) :
HEADSTAR MEDICAL PRODUCTS CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Headstar medical Small Volume Jet nebulizer creates respiratory mist out of the drug and is used to administer various aerosol treatments to adult and pediatric patients in homecare and hospital environments. It is not intended for transport use.
Based on practical measurement and comparison, Headstar Medical Small Volume Jet Nebulizer is intended for following populations:
HP-2557 Nebulizer with child face mask: 2~9 years old pediatric patients
HP-2558 Nebulizer with adult face mask: for adult patients
HP-2290 Nebulizer with mouth piece & O2 tubing: pediatric over 5 years and adult patients
HP-2291 Nebulizer with mouth/T piece & hose/O2 tubing: pediatric over 5 years and adult patients
The nebulizer operates on a compressed gas source which draws liquids from a refillable jar and aerosolizes it into respirable particles by impaction and baffling. Its use is indicated whenever a healthcare professional administers or prescribes medical aerosol products to a patient using a small volume nebulizer. It can be packaged with optional accessories; i.e .; oxygen tubing, mouthpiece, T piece, hose and face mask. Nebulizer bottle, T piece and mouthpiece are single patient re-use devices; while other accessories are single use/disposable devices. Headstar Medical small volume jet nebulizer is packed non-sterile in a polyethylene bag.
Device Description
The nebulizer operates on a compressed gas source which draws liquids from a refillable jar and aerosolizes it into respirable particles by impaction and baffling. Its use is indicated whenever a healthcare professional administers or prescribes medical aerosol products to a patient using a small volume nebulizer. It can be packaged with optional accessories; i.e .; oxygen tubing, mouthpiece, T piece, hose and face mask. Nebulizer bottle, T piece and mouthpiece are single patient re-use devices; while other accessories are single use/disposable devices. Headstar Medical small volume jet nebulizer is packed non-sterile in a polyethylene bag.
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K Number
K002846Device Name
HEADSTAR'S MANUAL EMERGENCY RESUSCITATOR
Manufacturer
HEADSTAR MEDICAL PRODUCTS CO., LTD
Date Cleared
2001-06-06
(267 days)
Product Code
BTM
Regulation Number
868.5915Why did this record match?
Applicant Name (Manufacturer) :
HEADSTAR MEDICAL PRODUCTS CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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