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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Oximeter
510(k) Number K091564
Device Name NBM-200MP PULSE OXIMETRY DEVICE
Applicant
ORSENSE LTD
20 HATA'AS ST
KFAR SABA,  IL 44425
Applicant Contact AHAVA STEIN
Correspondent
ORSENSE LTD
20 HATA'AS ST
KFAR SABA,  IL 44425
Correspondent Contact AHAVA STEIN
Regulation Number870.2700
Classification Product Code
DQA  
Date Received05/28/2009
Decision Date 03/19/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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