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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Network And Communication, Physiological Monitors
510(k) Number K193421
Device Name Smart Alarm Interface
Applicant
Boxview, LLC
14001 Mcauley Blvd. Suite 220
Oklahoma City,  OK  73134
Applicant Contact Cody Guest
Correspondent
Steurer Consulting Group
800 Blue Quail Rd.
Keller,  TX  76248
Correspondent Contact Robert Steurer
Regulation Number870.2300
Classification Product Code
MSX  
Date Received12/09/2019
Decision Date 10/30/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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