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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 K200480
Device Name DreamStation 2 System, DreamStation 2 Advanced System
Applicant
Respironics, Inc.
1001 Murry Ridge Lane
Murrysville,  PA  15668
Applicant Contact Andy Zaltwanger
Correspondent
Respironics, Inc.
1740 Golden Mile Highway
Monroeville,  PA  15146
Correspondent Contact Andy Zaltwanger
Regulation Number868.5905
Classification Product Code
BZD  
Subsequent Product Code
BZE  
Date Received02/27/2020
Decision Date 07/10/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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