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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessory To Continuous Ventilator (Respirator)
510(k) Number K161411
Device Name Care Cycle Connect Application
Applicant
RESPIRONICS, INC.
1001 MURRY RIDGE LN.
MURRYSVILLES,  PA  15668
Applicant Contact Colleen Witt
Correspondent
RESPIRONICS, INC.
1740 GOLDEN MILE HIGHWAY
MONROEVILLE,  PA  15146
Correspondent Contact Elaine Larkin
Regulation Number868.5895
Classification Product Code
MOD  
Date Received05/20/2016
Decision Date 02/17/2017
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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