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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name ventilator, emergency, manual (resuscitator)
510(k) Number K093081
Device Name POCKET BVM
Applicant
MICROBVM SYSTEMS LTD
POB 6718
EFRAT,  IL 90435
Applicant Contact ELI ORBACH
Correspondent
MICROBVM SYSTEMS LTD
POB 6718
EFRAT,  IL 90435
Correspondent Contact ELI ORBACH
Regulation Number868.5915
Classification Product Code
BTM  
Date Received10/01/2009
Decision Date 02/05/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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