MSX · System, Network And Communication, Physiological Monitors
Cardiovascular · 21 CFR 870.2300 · Class 2
Overview
| Product Code | MSX |
|---|---|
| Device Name | System, Network And Communication, Physiological Monitors |
| Regulation | 21 CFR 870.2300 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
| Life-Sustaining | Yes |
Identification
A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 117)
Showing 20 most recent of 117 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K253654 | IntelliVue Measurement Rack 6000 (867317) | Philips Medizin Systeme Böblingen GmbH | Mar 30, 2026 | SESE |
| K243270 | TigerConnect Alarm Management | Tigerconnect | Sep 30, 2025 | SESE |
| K242728 | BeneVision Central Monitoring System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | Jul 31, 2025 | SESE |
| K242750 | Central Station | Nihon Kohden Digital Health Solutions, LLC | Jun 5, 2025 | SESE |
| K242842 | ANNE View, Central Hub | Sibel Health, Inc. | Jan 8, 2025 | SESE |
| K241397 | Hinscope | Hinlab Sas | Nov 14, 2024 | SESE |
| K233834 | Infinity Gateway Suite | Draeger Medical Systems, Inc. | Jul 12, 2024 | SESE |
| K233418 | Biofourmis Everion+ (G2) | Biofourmis Singapore Pte., Ltd. | May 9, 2024 | SESE |
| K232548 | Corsano CardioWatch 287-2 System | Corsano Health B.V. | Mar 22, 2024 | SESE |
| K231506 | Current Health System | Current Health , Ltd. | Aug 24, 2023 | SESE |
| K223567 | CNS-2101 Central Monitor | Nihon Kohden Corporation | Jul 31, 2023 | SESE |
| K213863 | Everion+ System | Biofourmis Singapore Pte., Ltd. | Feb 23, 2023 | SESE |
| K222550 | Current Health System | Current Health , Ltd. | Nov 1, 2022 | SESE |
| K203579 | Infinity Gateway Suite | Draeger Medical Systems, Inc. | Jun 7, 2022 | SESE |
| K211046 | eCareManager 4.5 | Visicu, Inc. | Jun 3, 2022 | SESE |
| K220058 | BeneVision Central Monitoring System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | Jun 1, 2022 | SESE |
| K212622 | Zyter RPM | Zyter, Inc. | Feb 11, 2022 | SESE |
| K211949 | AirStrip ONE Web Client with Alarm Communication Management (ACM) | Airstrip Technologies, Inc. | Dec 9, 2021 | SESE |
| K210160 | AlertWatch:AC | Alertwatch, Inc. | Sep 10, 2021 | SESE |
| K210133 | Current Health Monitoring System Gen 2 (G2) | Current Health | Sep 3, 2021 | SESE |
Top Applicants
- Data Critical Corp. — 8 clearances
- Datex-Ohmeda — 8 clearances
- Shenzhen Mindray Bio-Medical Electronics Co., Ltd. — 7 clearances
- Draeger Medical Systems, Inc. — 5 clearances
- GE Healthcare — 5 clearances
