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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 Route 46 East
Batesville,  IN  47006
Applicant Contact Sarah Marie Fitzgerald
Correspondent
Hill-Rom Inc.
1069 State Route 46 East
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
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