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510(k) Data Aggregation
K Number
K980066Device Name
CPR FILTERSHIELD
Manufacturer
Date Cleared
1998-07-16
(190 days)
Product Code
Regulation Number
868.5915Why did this record match?
Applicant Name (Manufacturer) :
PLASCO, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The CPR FILTERSHIELD is a highly portable, single use, physical barrier for use in performing mouth-to mouth resuscitation on adults and children by personnel train in CPR techniques.
Device Description
The configuration of this device is a plastic PVC sheet with a hole in the center. Sealed around the hole is two plastic molded supports. An electret fiberous media filter is sealed to the proximal molded support.
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K Number
K953414Device Name
CPR MICROMASK WITH OXYGEN INLET
Manufacturer
Date Cleared
1996-03-20
(244 days)
Product Code
Regulation Number
868.5870Why did this record match?
Applicant Name (Manufacturer) :
PLASCO, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A device used for mouth-to-mask treatment of respiratory failure.
Device Description
The configuration of this pocket-sized device is a cushioned face mask used to enclose the patients nose and mouth. A one-way valve allows the rescuer to provide exhaled air to the patient. The oxygen port will allow oxygen enhancement of the rescuer's exhaled air. Expired air and/or fluids from the patient is vented away from the rescuer due to the one-way valve and an alternate venting route. The device comes in one size and is designed for adults but can be used on infants. By rotating the mask 180 degrees and placing the nose portion just below the infants lover lip, the wider portion of the cushion rests on the forehead. The repositioning of the mask and the soft material of the mask cushion allows for a complete seal of the mask cushion to an infants facial contours. The device is non-sterile. It normally will be packaged in a polybag which may be placed in a zippered nylon pouch. This device is not intended for use by persons not trained in basic life saving skills or those with only a basic bystander course.
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