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510(k) Data Aggregation
K Number
K032878Device Name
KUNG SHIN, HMEF SK203
Manufacturer
Date Cleared
2004-09-20
(371 days)
Product Code
Regulation Number
868.5260Why did this record match?
Applicant Name (Manufacturer) :
KUNG SHIN PLASTICS CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The HMEF SK203 is a disposable single-use device indicated for adult patients who require humidification during the delivery of ventilator gases and provide filtration for reducing contamination between patient and equipment. The HMEF SK203 is for use in hospital, ICU, anesthesia, respiratory therapy, during transport and for associated uses. The device can be used on adult patients. The device is indicated for use by qualified medical personnel only.
Device Description
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