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510(k) Data Aggregation
K Number
K021446Device Name
OEMEDIC INTERNATIONAL INC. BESMED SILICONE ADULT, CHILD, INFANT MANUAL RESUSCITATOR WITH MASK AND RESERVOIR
Manufacturer
Date Cleared
2002-10-11
(158 days)
Product Code
Regulation Number
868.5915Why did this record match?
Applicant Name (Manufacturer) :
OEMEDIC INTERNATIONAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The OEMedic International Inc. Besmed® Silicone Manual Resuscitators are intended to provide emergency ventilation or ventilation during patient transport, with air or air enriched with oxygen. The infant model is intended for patients weighing up to 10 kg, the child model is intended for patients weighing between 10 and 30 kg, and the adult model is intended for patients weighing more than 30 kg.
Device Description
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K Number
K021442Device Name
OEMEDIC INTERNATIONAL INC. BESMED SINGLE USE ADULT, CHILD, INFANT MANUAL RESUSCITATOR WITH MASK & RESERVOIR
Manufacturer
Date Cleared
2002-07-30
(85 days)
Product Code
Regulation Number
868.5915Why did this record match?
Applicant Name (Manufacturer) :
OEMEDIC INTERNATIONAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The OEMedic International Inc. Besmed® Single Use Manual Resuscitators are indicated to temporarily augment ventilation in patients.
Device Description
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