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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name display, cathode-ray tube, medical
510(k) Number K212208
Device Name Philips IntelliVue GuardianSoftware (Rev. E.0X)
Applicant
Philips Medizin Systeme Boeblingen GmbH
Hewlett-Packard Str. 2
Boeblingen,  DE 71034
Applicant Contact Johannes Schmid
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number870.2450
Classification Product Code
DXJ  
Subsequent Product Code
DQK  
Date Received07/15/2021
Decision Date 09/30/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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