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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 K202018
Device Name Hill-Rom Heart and Respiration Rate Monitoring System: Single Sensor, Hill-Rom Heart and Respiration Rate Monitoring System: Sensor Packs, Hill-Rom Heart and Respiration Rate Monitoring System: Sensor Activation
Applicant
Hill-Rom, Inc.
1069 State Route 46 E.
Batesville,  IN  47006
Applicant Contact Jigar Shah
Correspondent
Hill-Rom, Inc.
1069 State Route 46 E.
Batesville,  IN  47006
Correspondent Contact Jigar Shah
Regulation Number868.2375
Classification Product Code
BZQ  
Date Received07/21/2020
Decision Date 03/04/2021
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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