Product code MSX
- Device name
- System, Network And Communication, Physiological Monitors
- Medical specialty
- Cardiovascular
- Device class
- 2
- Regulation number
- 870.2300
- Review panel
- CV
- Implant
- N
- Life sustaining/supporting
- Y
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253654 | IntelliVue Measurement Rack 6000 (867317) | Philips Medizin Systeme Böblingen GmbH | 2026-03-30 |
| K243270 | TigerConnect Alarm Management | Tigerconnect | 2025-09-30 |
| K242728 | BeneVision Central Monitoring System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2025-07-31 |
| K242750 | Central Station | Nihon Kohden Digital Health Solutions, LLC | 2025-06-05 |
| K242842 | ANNE View, Central Hub | Sibel Health, Inc. | 2025-01-08 |
| K241397 | Hinscope | Hinlab Sas | 2024-11-14 |
| K233834 | Infinity Gateway Suite | Draeger Medical Systems, Inc. | 2024-07-12 |
| K233418 | Biofourmis Everion+ (G2) | Biofourmis Singapore Pte., Ltd. | 2024-05-09 |
| K232548 | Corsano CardioWatch 287-2 System | Corsano Health B.V. | 2024-03-22 |
| K231506 | Current Health System | Current Health , Ltd. | 2023-08-24 |
| K223567 | CNS-2101 Central Monitor | Nihon Kohden Corporation | 2023-07-31 |
| K213863 | Everion+ System | Biofourmis Singapore Pte., Ltd. | 2023-02-23 |
| K222550 | Current Health System | Current Health , Ltd. | 2022-11-01 |
| K203579 | Infinity Gateway Suite | Draeger Medical Systems, Inc. | 2022-06-07 |
| K211046 | eCareManager 4.5 | Visicu, Inc. | 2022-06-03 |
| K220058 | BeneVision Central Monitoring System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2022-06-01 |
| K212622 | Zyter RPM | Zyter, Inc. | 2022-02-11 |
| K210160 | AlertWatch:AC | Alertwatch, Inc. | 2021-09-10 |
| K210133 | Current Health Monitoring System Gen 2 (G2) | Current Health | 2021-09-03 |
| K202497 | Aulisa Multiple Patient Digital Vital Sign Monitoring System | Taiwan Aulisa Medical Devices Technologies, Inc. | 2020-10-30 |
| K193421 | Smart Alarm Interface | Boxview, LLC | 2020-10-30 |
| K192952 | Spire Health Remote Patient Monitoring System | Spire, Inc. D/B/A Spire Health | 2020-06-05 |
| K193391 | BeneVision Central Monitoring System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2020-05-21 |
| K193043 | Critical Alert CommonPath Enterprise | Critical Alert | 2020-05-11 |
| K191272 | Wearable Device, Wearable Package | Current Health , Ltd. | 2019-07-12 |
| K182637 | Philips IntelliVue XDS Software | Philips Medizin Systeme Boeblingen GmbH | 2019-04-26 |
| K190073 | Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case without Homehub | Current Health , Ltd. | 2019-03-27 |
| K183238 | BeneVision Central Monitoring System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2019-03-13 |
| K180430 | Digistat Smart Central | Ascom Ums Srl Unipersonale | 2018-11-23 |
| K182543 | Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device Charger ; Hospital Starter Package | Snap40, Ltd. | 2018-11-14 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| B153500010 | AirStrip Alarm Management | Airstrip Technologies, Inc. | 2026-03-18 |
| B153301030 | AirStrip ONE Client Web | Airstrip Technologies, Inc. | 2026-03-18 |
| B153300010 | AirStrip ONE Platform | Airstrip Technologies, Inc. | 2026-03-18 |
| G2871002 | HUMA | MedoPad Inc. | 2025-04-28 |
| 10841522131141 | Xhibit | SPACELABS HEALTHCARE (WASHINGTON), INC | 2024-07-04 |
| 08720256776529 | Corsano CardioWatch 287-2 System | Corsano Health B.V. | 2024-06-19 |
| 10841522129780 | Xhibit | SPACELABS HEALTHCARE (WASHINGTON), INC | 2024-06-07 |
| 10841522117688 | XHIBIT | SPACELABS HEALTHCARE (WASHINGTON), INC | 2024-06-07 |
| 08885018690090 | Everion+ System Adjustable Armband | BIOFOURMIS SINGAPORE PTE. LTD. | 2023-05-02 |
| 08885018690106 | Everion+ System Adjustable Armband | BIOFOURMIS SINGAPORE PTE. LTD. | 2023-05-02 |
| 08885018690007 | Everion+ System | BIOFOURMIS SINGAPORE PTE. LTD. | 2023-03-22 |
| 17350097870032 | Digistat Smart Central | ASCOM UMS SRL | 2019-03-15 |
| 10841522124754 | Spacelabs Healthcare | SPACELABS HEALTHCARE (WASHINGTON), INC | 2018-05-09 |
| B15320000 | AirStrip ONE | Airstrip Technologies, Inc. | 2017-10-09 |
| 10841522120190 | Xhibit Telemetry Receiver | SPACELABS HEALTHCARE (WASHINGTON), INC | 2017-01-23 |
| 20884838072248 | Spirometry Sensor | Philips Medizin Systeme Böblingen GmbH | 2017-01-20 |
| 10841522120282 | Spacelabs Healthcare | SPACELABS HEALTHCARE (WASHINGTON), INC | 2017-01-10 |
| 10841522120237 | Spacelabs Healthcare | SPACELABS HEALTHCARE (WASHINGTON), INC | 2017-01-06 |
| 10841522120268 | Spacelabs Healthcare | SPACELABS HEALTHCARE (WASHINGTON), INC | 2017-01-06 |
| 10841522120206 | Spacelabs Healthcare | SPACELABS HEALTHCARE (WASHINGTON), INC | 2017-01-03 |
| 10841522102707 | XTR | SPACELABS HEALTHCARE (WASHINGTON), INC | 2017-01-03 |
| 10841522102868 | Spacelabs Healthcare | SPACELABS HEALTHCARE (WASHINGTON), INC | 2016-12-22 |
| 10841522102738 | Spacelabs Healthcare | SPACELABS HEALTHCARE (WASHINGTON), INC | 2016-12-22 |
| 10841522102721 | Spacelabs Healthcare | SPACELABS HEALTHCARE (WASHINGTON), INC | 2016-12-22 |
| 10841522102691 | Spacelabs Healthcare | SPACELABS HEALTHCARE (WASHINGTON), INC | 2016-12-22 |
| 10841522100345 | Xhibit | SPACELABS HEALTHCARE (WASHINGTON), INC | 2016-10-04 |
| 10841522107832 | Xhibit | SPACELABS HEALTHCARE (WASHINGTON), INC | 2016-10-04 |
| 10841522107160 | Xhibit | SPACELABS HEALTHCARE (WASHINGTON), INC | 2016-10-04 |
| 10841522100246 | Xhibit Telemetry Receiver | SPACELABS HEALTHCARE (WASHINGTON), INC | 2016-09-22 |
| 10841522106514 | XTR | SPACELABS HEALTHCARE (WASHINGTON), INC | 2016-09-22 |