Cerebra Sleep System

Standard Polysomnograph With Electroencephalograph

Cerebra Medical Ltd.

The following data is part of a premarket notification filed by Cerebra Medical Ltd. with the FDA for Cerebra Sleep System.

Pre-market Notification Details

Device IDK213007
510k NumberK213007
Device Name:Cerebra Sleep System
ClassificationStandard Polysomnograph With Electroencephalograph
Applicant Cerebra Medical Ltd. 1470 Wilson Place Unit B Winnipeg,  CA R3T2N9
ContactSharon Cholowsky
CorrespondentMary Vater
Medical Device Academy Inc. 345 Lincoln Hill Road Shrewsbury,  VT  05738
Product CodeOLV  
Subsequent Product CodeOLZ
Subsequent Product CodeOMC
CFR Regulation Number882.1400 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-09-20
Decision Date2022-07-06


Device IdentifiersubmissionNumberSupplement
B600700014 K213007 000

© 2022 FDA.report
This site is not affiliated with or endorsed by the FDA.