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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Breathing Frequency
510(k) Number K180079
Device Name Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Packs (different #), Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Activation
Applicant
Hill-Rom, Inc.
1069 State Rte. 46 E.
Batesville,  IN  47006
Applicant Contact Sarah Marie Fitzgerald
Correspondent
Hill-Rom, Inc.
1069 State Rte. 46 E.
Batesville,  IN  47006
Correspondent Contact Sarah Marie Fitzgerald
Regulation Number868.2375
Classification Product Code
BZQ  
Date Received01/10/2018
Decision Date 05/07/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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