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510(k) Data Aggregation
K Number
K021716Device Name
SIMPLIFY COMPACT RESUSCITATOR
Manufacturer
Date Cleared
2002-10-08
(138 days)
Product Code
Regulation Number
868.5915Why did this record match?
Applicant Name (Manufacturer) :
POLYMED (XIAMEN) PLASTIC INDUSTRIAL CO.,LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The SIMPLIFY COMPACT RESUSCITATOR are manual resuscitators incorporating a bag and valve, intended to provide emergency ventilation or ventilation during patient transport. The infant model is intended for patients weighing between 5 to 12 kgs, the child model is intended for patients weighing between 10 to 30 kgs, and the adult model is intended for patients weighing more than 30 kgs approximate weight. The SIMPLIFY COMPACT RESUSCITATOR provided in reusable models and in the disposable models.
Device Description
manual resuscitators incorporating a bag and valve
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