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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Automatic Event Detection Software For Polysomnograph With Electroencephalograph
510(k) Number K202142
Device Name Sleepware G3
Applicant
Respironics, Inc.
1001 Murry Ridge Lane
Murrysville,  PA  15668
Applicant Contact Jonquil Mau
Correspondent
Respironics, Inc.
1001 Murry Ridge Lane
Murrysville,  PA  15668
Correspondent Contact Jonquil Mau
Regulation Number882.1400
Classification Product Code
OLZ  
Date Received07/31/2020
Decision Date 10/29/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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