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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 K182401
Device Name B.O.L.T Base Unit, B.O.L.T Non-Invasive Blood Pressure (NIBP) Cuff, B.O.L.T Infared Radiation Energy Technology(IRT) Thermometer probe, B.O.L.T Pulse Oximeter(SPO2) probe, B.O.L.T Gluchobin Blood Glucose, Total Cholesterol and Hemoglobin meter
Applicant
Amzetta Technologies Private Limited
Kumaran Nagar, Semmanchery, Off Rajiv Gandhi Salai (Omr)
Chennai,  IN 600 119
Applicant Contact Sridharan Mani
Correspondent
Amzetta Technologies Private Limited
Kumaran Nagar, Semmanchery, Off Rajiv Gandhi Salai (Omr)
Chennai,  IN 600 119
Correspondent Contact Sridharan Mani
Regulation Number870.2300
Classification Product Code
MWI  
Subsequent Product Codes
DQA   DXN   FLL  
Date Received09/04/2018
Decision Date 08/28/2019
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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