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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 K192624
Device Name ApneaTrak
Applicant
Cadwell Industries, Inc.
909 N. Kellogg Street
Kennewick,  WA  99336
Applicant Contact James Blevins
Correspondent
Cadwell Industries, Inc.
909 N. Kellogg Street
Kennewick,  WA  99336
Correspondent Contact James Blevins
Regulation Number882.1400
Classification Product Code
OLV  
Subsequent Product Code
MNR  
Date Received09/23/2019
Decision Date 02/20/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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