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510(k) Data Aggregation
K Number
K073410Device Name
SAVE RESUSCITATOR
Manufacturer
Date Cleared
2008-09-12
(283 days)
Product Code
Regulation Number
868.5915Why did this record match?
Applicant Name (Manufacturer) :
ARTIVENT CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The SAVe™ Resuscitator is intended for manual pulmonary resuscitation and emergency respiratory support. SAVe Resuscitator is intended for patients with a body mass of more than 15kg (~33 lbs), approx. 3 years of age.
Device Description
The SAVe™ Manual Resuscitator is a hand operated resuscitator that provides control of the volume of delivered ventilation gas (air or oxygenenriched gas).
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