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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
510(k) Number K161909
Device Name IQvitals Zone
Applicant
Midmark Corporation
690 Knox St., Suite 100
Torrance,  CA  90502
Applicant Contact Asad Abu-Tarif
Correspondent
Midmark Corporation
690 Knox St., Suite 100
Torrance,  CA  90502
Correspondent Contact Maria Moreno
Regulation Number870.2300
Classification Product Code
MWI  
Subsequent Product Codes
DQA   DXN   FLL  
Date Received07/12/2016
Decision Date 11/17/2016
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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