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510(k) Data Aggregation
K Number
K142764Device Name
KYOLING CPR Mask with Oxygen Port and Without Oxygen Port
Manufacturer
HANGZHOU JINLIN MEDICAL APPLIANCES CO., LTD.
Date Cleared
2015-07-09
(287 days)
Product Code
CBP, III
Regulation Number
868.5870Why did this record match?
Applicant Name (Manufacturer) :
HANGZHOU JINLIN MEDICAL APPLIANCES CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CPR Mask with Oxygen Port is designed to assist in providing immediate life support (mouth to health emergency victims requiring oxygen support (inhalation) or cardiopulmonary resuscitation (CPR) rescue techniques. The CPR Mask with Oxygen Port is for prescription use.
The CPR Mask without Oxygen Port is designed to assist in providing immediate life support (mouth to health emergency victims requiring cardiopulmonary resuscitation (CPR) resuscitator without oxygen port is for overthe-counter use.
Device Description
The KYOLING CPR mask is used during cardiopulmonary resuscitation procedures, which are used in emergency situations to supply oxygen and produce blood flow in the heart and lungs.
The CPR mask is made of PVC and one-way valve made of medical grade K-resin, the mask is used for mouth-to-mask breathing, it provides a physical barrier between the rescuer and victim, eliminating direct contact of the rescuer's lips with the unknown subject; and also it promotes an airtight seal to the face allowing ventilation through both the mouth and nose simultaneously. The KYOLING CPR Mask includes transparent dome, universal breathing tube, one-way filtered valve, head strap, and with Oxygen Port or without Oxygen Port.
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