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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Sleep Assessment
510(k) Number K003499
Device Name REMVIEW SLEEP RECORDER, MODEL 320
Applicant
Respironics, Inc.
1001 Murry Ridge Ln.
Murrysville,  PA  15668
Applicant Contact DAVID J VANELLA
Correspondent
Respironics, Inc.
1001 Murry Ridge Ln.
Murrysville,  PA  15668
Correspondent Contact DAVID J VANELLA
Regulation Number882.5050
Classification Product Code
LEL  
Date Received11/13/2000
Decision Date 02/09/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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