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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
510(k) Number K181311
Device Name Philips Hemodynamic Application R1.0
Applicant
Philips Medical Systems Nederlands B.V.
Veenpluis 4-6
Best Noord-Brabant,  NL 5684 pc
Applicant Contact Owen Callaghan
Correspondent
Philips Medical Systems Nederlands B.V.
Veenpluis 4-6
Best Noord-Brabant,  NL 5684 pc
Correspondent Contact Owen Callaghan
Regulation Number870.2300
Classification Product Code
MWI  
Date Received05/17/2018
Decision Date 09/07/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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