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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Attachment, Breathing, Positive End Expiratory Pressure
510(k) Number K900113
Device Name RESPIRONICS' REMSTAR(TM) SLEEPEASY
Applicant
Respironics, Inc.
1001 Murry Ridge Ln.
Murrysville,  PA  15668
Applicant Contact EUGENE N SCARBERRY
Correspondent
Respironics, Inc.
1001 Murry Ridge Ln.
Murrysville,  PA  15668
Correspondent Contact EUGENE N SCARBERRY
Regulation Number868.5965
Classification Product Code
BYE  
Date Received01/09/1990
Decision Date 03/28/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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