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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name pillow, cervical (for mild sleep apnea)
510(k) Number K140190
FOIA Releasable 510(k) K140190
Device Name NIGHT SHIFT
Applicant
ADVANCED BRAIN MONITORING, INC.
W324 S3649 COUNTY RD E
DOUSMAN,  WI  53118
Applicant Contact ADRIENNE LENZ
Correspondent
ADVANCED BRAIN MONITORING, INC.
W324 S3649 COUNTY RD E
DOUSMAN,  WI  53118
Correspondent Contact ADRIENNE LENZ
Regulation Number872.5570
Classification Product Code
MYB  
Date Received01/24/2014
Decision Date 05/29/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Clinical Trials NCT02032706
Reviewed by Third Party No
Combination Product No
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