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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Standard Polysomnograph With Electroencephalograph
510(k) Number K213007
Device Name Cerebra Sleep System
Applicant
Cerebra Medical , Ltd.
1470 Wilson Place
Unit B
Winnipeg,  CA R3T2N9
Applicant Contact Sharon Cholowsky
Correspondent
Medical Device Academy, Inc.
345
Lincoln Hill Rd.
Shrewsbury,  VT  05738
Correspondent Contact Mary Vater
Regulation Number882.1400
Classification Product Code
OLV  
Subsequent Product Codes
OLZ   OMC  
Date Received09/20/2021
Decision Date 07/06/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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