510(k) K242962

Device: Telemetry Monitor 5500 Release 4.0 (867232)
Applicant: Philips Medizin Systeme Böblingen GmbH
510(k) number: K242962
Product code: MHX
Decision: Substantially Equivalent (SESE)
Decision date: 2025-05-05
Date received: 2024-09-25
Regulation: 870.1025
Classification name: Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Medical specialty: Cardiovascular
Review panel: Cardiovascular
Device class: 2
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: N

Related Records

Applicant Contact

Contact: Mary Couch
Address: Hewlett-Packard Strasse 2 Böblingen DE 71034 71034

FDA Registration Numbers

3015181391
9710602
3004526608
3007734888
1000484830
3014541700
3008716327
3013501110
3019388613
3008363989
3010157426
3009443693
3003832357
3030516450
8022257
3009499478
3004977335
1066270
3015997711
3004196561
3014633893
9681377
3010698831
3018783526
3043479346
3021736577
3003591740
9611500
3013596024
3013500228
3013679558
9610816
3010703925
3014848734
3011120183
3009673645
3005906887
3009490946
2032233
3007836437
3005877899
3008483389
3006979678
3006147705
3004832480
9611031
3012972516
3016852448
3009607734
3008058135
3013314298
8030978
3005521864
3003589956
3003263092
3016931915
3007413079
3001104093
3007603826
3006087789
3023272766
3009831876
3030597679
3004415095
3020115
3012359877
3014263632
3007481893
1651104
3003971136
3006606827
3012104670
1316463
3012238587
3015328411
3009077524
3016618143
3021559257
3017446092
3010536822

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code MHX

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K242562	Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P	Ge Medical Systems Information Technologies, Inc.	2025-07-09
K250757	Radius VSM and Accessories	Masimo Corporation	2025-05-29
K240312	Infinity CentralStation Wide	Draeger Medical Systems, Inc.	2024-08-01
K240320	Patient Monitor (RespArray)	Edan Instruments, Inc.	2024-06-28