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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 K181053
Device Name Care Orchestrator
Applicant
Respironics Inc.
1001 Murry Ridge Lane
Murrysville,  PA  15668
Applicant Contact Ankitha Rao
Correspondent
Respironics Inc.
1001 Murry Ridge Lane
Murrysville,  PA  15668
Correspondent Contact Ankitha Rao
Regulation Number868.5905
Classification Product Code
BZD  
Subsequent Product Codes
CAW   CBK   MNS   MNT   NOU  
Date Received04/20/2018
Decision Date 01/04/2019
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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