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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calculator, Drug Dose
510(k) Number K160673
Device Name Insulin Algorithms System
Applicant
Insulin Algorithms
9538 W.Pico Blvd. #206
Los Angeles,  CA  90035
Applicant Contact Josh Davidson
Correspondent
Medtech Consultants, Inc.
20370 Skyhawk Ln.
Topanga,  CA  90290
Correspondent Contact Sigi Caron
Regulation Number868.1890
Classification Product Code
NDC  
Date Received03/10/2016
Decision Date 06/07/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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