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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Computer, Diagnostic, Programmable
510(k) Number K212493
Device Name KODEX – EPD™ System 1.5.0
Applicant
Philips Medical Systems Nederland, B.V. (Pmsn)
Veenpluis 4-6
Best Noord-Brabant,  NL 5684 pc
Applicant Contact Betina Schepers
Correspondent
Philips Medical Systems Nederland, B.V. (Pmsn)
Veenpluis 4-6
Best Noord-Brabant,  NL 5684 pc
Correspondent Contact Betina Schepers
Regulation Number870.1425
Classification Product Code
DQK  
Date Received08/09/2021
Decision Date 10/24/2022
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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