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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
510(k) Number K200107
Device Name epoc Blood Analysis System
Applicant
Epocal Inc.
2060 Walkley Road
Ottawa,  CA K1G 3P5
Applicant Contact Amanda Barriage
Correspondent
Epocal Inc.
2060 Walkley Road
Ottawa,  CA K1G 3P5
Correspondent Contact Amy Goldberg
Regulation Number862.1120
Classification Product Code
CHL  
Subsequent Product Codes
CDS   CEM   CGA   CGL   CGZ  
JFL   JFP   JGS   JPI   KHP  
Date Received01/17/2020
Decision Date 06/05/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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