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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 K190487
Device Name InPen Dose Calculator
Applicant
Companion Medical, Inc.
11011 Via Frontera
Suite D
San Diego,  CA  92127
Applicant Contact Jasper Benke
Correspondent
Companion Medical, Inc.
11011 Via Frontera
Suite D
San Diego,  CA  92127
Correspondent Contact Jasper Benke
Regulation Number868.1890
Classification Product Code
NDC  
Date Received02/28/2019
Decision Date 02/18/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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