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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(With Arrhythmia Detection Or Alarms)
510(k) Number K242962
Device Name Telemetry Monitor 5500 Release 4.0 (867232)
Applicant
Philips Medizin Systeme Böblingen GmbH
Hewlett-Packard Strasse 2
Böblingen,  DE 71034
Applicant Contact Mary Couch
Correspondent
Philips Medizin Systeme Böblingen GmbH
Hewlett-Packard Strasse 2
Böblingen,  DE 71034
Correspondent Contact Mary Couch
Regulation Number870.1025
Classification Product Code
MHX  
Subsequent Product Codes
DQA   DRG   DRT   DRW   DSA  
DSI   MLD   MSX  
Date Received09/25/2024
Decision Date 05/05/2025
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
Recalls CDRH Recalls
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