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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 K172711
Device Name Comet-PLUS
Applicant
Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)
2568 Bristol Circle
Oakville,  CA l6h 5s1
Applicant Contact Sanjay Mehta
Correspondent
Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)
2568 Bristol Circle
Oakville,  CA l6h 5s1
Correspondent Contact Sanjay Mehta
Regulation Number882.1400
Classification Product Code
OLV  
Subsequent Product Code
GWQ  
Date Received09/08/2017
Decision Date 11/03/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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