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510(k) Data Aggregation
K Number
K210288Device Name
Disposable Manual Resuscitator
Manufacturer
Xiamen Compower Medical Tech. Co., Ltd.
Date Cleared
2021-08-26
(205 days)
Product Code
BTM
Regulation Number
868.5915Why did this record match?
Applicant Name (Manufacturer) :
Xiamen Compower Medical Tech. Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Single patient use manual resuscitator for use in hospital, transport, emergency, and post-hospital care to temporary ventilate a patient for the given body mass ranges of: Infant: less than or equal to 10 kg Child: less than or equal to 23 kg Adult: greater than 23 kg
Device Description
Disposable manual resuscitator is disposable, medical device, which temporarily augment ventilation in patients during ventilatory insufficiency or ventilator failure. Disposable manual resuscitator uses a duck-bill valve in the non-rebreathing valve assembly, attaches the non-rebreathing valve directly onto the resuscitation bag and includes an oxygen enrichment (reservoir) system. Disposable manual resuscitator may be used in hospital, transport, emergency, and post hospital care to temporary ventilate a patient. Disposable manual resuscitator is for single patient used. It comprises of mask, oxygen tube, reservoir bag and resuscitator bag. It is used to temporary ventilate a patient for the given body mass ranges of: Infant - Less than or equal to 10 kg Child - less than or equal to 23 kg Adult - Greater than 23 kg.
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