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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Non-Continuous (Respirator)
510(k) Number K010263
Device Name REMSTAR PLUS CPAP SYSTEM
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 Number868.5905
Classification Product Code
BZD  
Subsequent Product Code
BTT  
Date Received01/29/2001
Decision Date 03/29/2001
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
Recalls CDRH Recalls
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