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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 K163664
Device Name Health-e-Connect System with IDA
Applicant
Alr Technologies
7400 Beaufont Springs Dr. Suite 300
North Chesterfield,  VA  23225
Applicant Contact SIDNEY CHAN
Correspondent
Alr Technologies
7400 Beaufont Springs Dr. Suite 300
North Chesterfield,  VA  23225
Correspondent Contact PAUL DRYDEN
Regulation Number868.1890
Classification Product Code
NDC  
Date Received12/27/2016
Decision Date 09/18/2017
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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