Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart B — Cardiovascular Diagnostic Devices](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices) → [21 CFR 870.1025](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/870.1025) → MHX — Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) # MHX · Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) _Cardiovascular · 21 CFR 870.1025 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MHX ## Overview - **Product Code:** MHX - **Device Name:** Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) - **Regulation:** [21 CFR 870.1025](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/870.1025) - **Device Class:** 2 - **Review Panel:** [Cardiovascular](/submissions/CV) ## Identification The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs. ## Classification Rationale Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document. ## Special Controls *Classification.* Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document. ## Recent Cleared Devices (20 of 421) Showing 20 most recent of 421 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K253170](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MHX/K253170.md) | uMEC 60/ uMEC 70/ uMEC 80/uMEC 100/uMEC 120/uMEC 150 Patient Monitors | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | Apr 16, 2026 | SESE | | [K252250](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MHX/K252250.md) | 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. | Apr 10, 2026 | SESE | | [K252726](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MHX/K252726.md) | IntelliVue Multi-Measurement Module X3 (867030); IntelliVue Patient Monitor MX100 (867033); IntelliVue MMX (867036) | Philips Medizin Systeme Boeblingen GmbH | Feb 6, 2026 | SESE | | [K252589](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MHX/K252589.md) | Corvair Monza | AliveCor, Inc. | Jan 9, 2026 | SESE | | [K250854](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MHX/K250854.md) | 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) | Shenzhen Comen Medical Instruments Co.,Ltd | Dec 17, 2025 | SESE | | [K251702](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MHX/K251702.md) | IntelliVue Patient Monitor MX750; IntelliVue Patient Monitor MX850; IntelliVue 4-Slot Module Rack FMX-4 (866471 866470 866468 ) | Philips Medizin Systeme Böblingen GmbH | Nov 10, 2025 | SESE | | [K251146](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MHX/K251146.md) | IntelliVue Patient monitors MX400, MX450, MX500, MX550 | Philips Medizin Systeme Boeblingen GmbH | Oct 17, 2025 | SESE | | [K250453](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MHX/K250453.md) | IntelliVue Patient Monitor 6100 (6100); IntelliVue Patient Monitor 6300 (6300); IntelliVue Patient Monitor 6500 (6500) | Philips Medizin Systeme Böblingen GmbH | Sep 2, 2025 | SESE | | [K250179](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MHX/K250179.md) | Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15) | Edan Instruments, Inc. | Jul 29, 2025 | SESE | | [K242562](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MHX/K242562.md) | Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P | Ge Medical Systems Information Technologies, Inc. | Jul 9, 2025 | SESE | | [K250757](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MHX/K250757.md) | Radius VSM and Accessories | Masimo Corporation | May 29, 2025 | SESE | | [K242962](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MHX/K242962.md) | Telemetry Monitor 5500 Release 4.0 (867232) | Philips Medizin Systeme Böblingen GmbH | May 5, 2025 | SESE | | [K240312](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MHX/K240312.md) | Infinity CentralStation Wide | Draeger Medical Systems, Inc. | Aug 1, 2024 | SESE | | [K240320](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MHX/K240320.md) | Patient Monitor (RespArray) | Edan Instruments, Inc. | Jun 28, 2024 | SESE | | [K231010](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MHX/K231010.md) | Corvair | AliveCor, Inc. | Jun 7, 2024 | SESE | | [K232962](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MHX/K232962.md) | Patient Monitor (iX10, iX12, iX15) | Edan Instruments, Inc. | Apr 19, 2024 | SESE | | [K232694](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MHX/K232694.md) | Central Monitoring System (MFM-CMS) | Edan Instruments, Inc. | Feb 5, 2024 | SESE | | [K231671](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MHX/K231671.md) | IntelliVue Patient Monitor MX750 (866471), IntelliVue Patient Monitor MX850 (866470), IntelliVue 4-Slot Module Rack FMX-4 (866468) | Philips Medizin Systeme Boeblingen GmbH | Dec 19, 2023 | SESE | | [K230604](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MHX/K230604.md) | IntelliVue Patient Monitor MX100 (867033), IntelliVue Multi-Measurement Module X3 (867030) | Philips Medizin Systeme Boeblingen GmbH | Nov 22, 2023 | SESE | | [K231477](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MHX/K231477.md) | Infinity CentralStation Wide, Infinity M300, Infinity M300+ | Draeger Medical Systems, Inc. | Oct 17, 2023 | SESE | ## Top Applicants - Philips Medizin Systeme Boeblingen GmbH — 25 clearances - Draeger Medical Systems, Inc. — 24 clearances - Ge Medical Systems Information Technologies — 24 clearances - Philips Medical Systems — 24 clearances - Shenzhen Mindray Bio-Medical Electronics Co., Ltd. — 21 clearances --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MHX](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MHX) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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