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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name hemoglobin for donor testing
510(k) Number BK190322
Tradename NBM-200 Pulse Oximeter and Hemoglobin Monitor
Device Name Hemoglobin for donor testing
Original Applicant
OrSense Ltd
17 ha’mefalsim st
petah tikva,  Kiryat Arie,  4951447, 
Regulation Number864.7500
Classification Product Code
QGU  
Date Received02/12/2019
Decision Date 05/09/2019
Decision substantially equivalent (SE)
Classification Advisory Committee Hematology
Review Advisory Committee Hematology
Type 510(k) Traditional
Total Product Life Cycle (TPLC) TPLC Device Report
Reviewed by Third Party No
Expedited Review No
Combination Product No
In Vitro Product No
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