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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cerebral Oximeter
510(k) Number K182242
Device Name VO200 – NeurOs Cerebral Oximetry System
Applicant
Mespere Lifesciences, Inc.
180 Frobisher Dr. Suite 1c
Waterloo,  CA N2V2A2
Applicant Contact Rebecca S. Li
Correspondent
Mespere Lifesciences, Inc.
180 Frobisher Dr. Suite 1c
Waterloo,  CA N2V2A2
Correspondent Contact Rebecca S. Li
Regulation Number870.2700
Classification Product Code
QEM  
Date Received08/20/2018
Decision Date 12/26/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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