510(k) K250854

Device: Multi-parameter Patient Monitor (N10); Multi-parameter Patient Monitor (N12); Multi-parameter Patient Monitor (N15); Multi-parameter Patient Monitor (N10MPro); Multi-parameter Patient Monitor (N12MPro); Multi-parameter Patient Monitor (N15MPro)
Applicant: Shenzhen Comen Medical Instruments Co.,Ltd
510(k) number: K250854
Product code: MHX
Decision: Substantially Equivalent (SESE)
Decision date: 2025-12-17
Date received: 2025-03-21
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: Charlotte Lin
Address: Floor 10, Floor 11 And Sec C Of Floor 12 Of Bldg. 1a & Floor Of Bldg. 2, Fiyta Timepiece Bldg, Nanhuan Ave. Matian Sub-Di Shenzhen CN 518106 518106

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

510(k)	Device	Applicant	Decision date
K260098	ePM Series Patient Monitor (ePM 10/ePM 10A/ePM 10C/Guardian plus/ ePM 12/ePM 12A/ePM 12C / ePM 15/ePM 15A/ePM 15C /ePM 10M/ ePM 10MA/ ePM 10MC/ePM 12M/ ePM 12MA/ ePM 12MC/ePM 15M/ ePM 15MA/ ePM 15MC)	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	2026-05-20
K250349	Vista CMS	Shanghai Draeger Medical Instrument Co., Ltd.	2026-04-24
K253170	uMEC 60/ uMEC 70/ uMEC 80/uMEC 100/uMEC 120/uMEC 150 Patient Monitors	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	2026-04-16
K252250	Vista 300/Vista 300 S; Vista 300 Non-Inv Model A, US (2601064); Vista 300 Invasive Model C, US (2601065); Vista 300 S Non-Inv Model A, US (2602425); Vista 300 S Invasive Model B, US (2602426); Vista 300 S Invasive Model C, US (2602427)	Shanghai Draeger Medical Instrument Co., Ltd.	2026-04-10
K252726	IntelliVue Multi-Measurement Module X3 (867030); IntelliVue Patient Monitor MX100 (867033); IntelliVue MMX (867036)	Philips Medizin Systeme Boeblingen GmbH	2026-02-06
K252589	Corvair Monza	AliveCor, Inc.	2026-01-09
K251702	IntelliVue Patient Monitor MX750; IntelliVue Patient Monitor MX850; IntelliVue 4-Slot Module Rack FMX-4 (866471 866470 866468 )	Philips Medizin Systeme Böblingen GmbH	2025-11-10
K251146	IntelliVue Patient monitors MX400, MX450, MX500, MX550	Philips Medizin Systeme Boeblingen GmbH	2025-10-17
K250453	IntelliVue Patient Monitor 6100 (6100); IntelliVue Patient Monitor 6300 (6300); IntelliVue Patient Monitor 6500 (6500)	Philips Medizin Systeme Böblingen GmbH	2025-09-02
K250179	Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15)	Edan Instruments, Inc.	2025-07-29
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
K242962	Telemetry Monitor 5500 Release 4.0 (867232)	Philips Medizin Systeme Böblingen GmbH	2025-05-05
K240312	Infinity CentralStation Wide	Draeger Medical Systems, Inc.	2024-08-01
K240320	Patient Monitor (RespArray)	Edan Instruments, Inc.	2024-06-28