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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K253654
Device Name IntelliVue Measurement Rack 6000 (867317)
Applicant
Philips Medizin Systeme Böblingen GmbH
Hewlett-Packard-Str. 2
Boeblingen,  DE 71034
Applicant Contact Monica da Silva
Correspondent
Philips Medizin Systeme Böblingen GmbH
Hewlett-Packard-Str. 2
Boeblingen,  DE 71034
Correspondent Contact Monica da Silva
Date Received11/20/2025
Decision Date 03/30/2026
Decision Substantially Equivalent (SESE)
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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