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510(k) Data Aggregation
K Number
K093081Device Name
POCKET BVM
Manufacturer
Date Cleared
2010-02-05
(127 days)
Product Code
Regulation Number
868.5915Why did this record match?
Applicant Name (Manufacturer) :
MICROBVM SYSTEMS LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Pocket BVM Resuscitator is intended for manual pulmonary resuscitation and emergency respiratory support of adult patients.
Device Description
The Pocket BVM is a manual emergency ventilator device whose purpose is to manually apply positive pressure to a patient's airways to support ventilation and oxygenation. The Pocket BVM incorporates bags and valve assemblies and is intended to provide emergency respiratory support to a patient through a face mask or a tube inserted into the patient's airway.
The Pocket BVM can apply ventilation to a patient either through a mask (supplied with the device) or an artificial airway (not supplied). The Pocket BVM device maintains the functionality of existing devices and also has the advantage of small external dimensions (when packed) and light weight. It can be unpacked and made operational in seconds. The Pocket BVM complies with ISO 10651-4:2002; Particular requirements for operator powered resuscitators.
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