Sickbay Clinical Platform
The Sickbay Clinical Platform gathers physiological data streams from supported patient monitors and other clinical sources. In hospitals, it captures and stores medical device data and…
The Sickbay Clinical Platform gathers physiological data streams from supported patient monitors and other clinical sources. In hospitals, it captures and stores medical device data and diagnostic information and routes data to electronic medical records and clinical information systems.
Healthcare professionals can remotely review patient data, waveforms and alarms in near real time. The platform supports consultation about a patient’s status and provides information for clinical decisions alongside the hospital’s existing monitoring equipment.
Listed Item
Sickbay Clinical Platform is a software product that is intended to run on hospital servers on a hospital’s secure network. It gathers and stores all the physiological sensor data from patients admitted to the ER or ICU and is capable of re-displaying all the physiological sensor data in real-time when gathered or at any later time. The Sickbay Clinical Platform can be thought of as three distinct subsystems working together. The first subsystem is called the Sickbay Informatics server. This component does most of the work involving acquisition and archiving physiological data, executing data processing and data management functionality, and serving data on request to clients. The second component of sickbay is a database. The database is used to organize all of the relationships between data on the sickbay system. The third component of the Sickbay Clinical Platform is a web-server used for data visualization.
Alarm Review
The platform includes patient monitoring, patient alarm data monitoring and an alarm analytics dashboard. It supplements the hospital’s device monitoring and must not serve as the sole source of alarms. Its role is to present and organize supported device data for healthcare staff.
Who Else Makes It
Concentrated in Guangdong (10), Beijing (2), Jiangsu (1). 8 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
| Shenzhen Comen Medical Instruments Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 24 |
| Amphenol Alden Products Company | Shenzhen | Guangdong | Contract manufacturer | 24 |
| Tianjin Choice Medical Device Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 12 |
| Wuhan Strong Electronics | Wuhan | Hubei | Contract manufacturer | 6 |
| VTech Communications Ltd | Dongguan | Guangdong | Contract manufacturer | 5 |
| Armorlink SH Corp | Shanghai | Shanghai | Contract manufacturer | 2 |
| Tontec Precision Plastics Technology (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 1 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
| Edan Instruments, Inc. | Shenzhen | Guangdong | Contract manufacturer | 56 |
| Beijing Choice Electronic Technololgy Co., Ltd. | Beijing | Beijing | Repacker / relabeller | 30 |
Showing 12 of 17. All 17 manufacturers in China registered for Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Record
| Listed by | Medical Informatics Corp., United States |
|---|---|
| FDA product code | MWI |
| Device type | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2300 |
| Establishment | Manufacturer |
| 510(k) | K143304 |
| Record published | 2019-03-08 |
| Record revised | 2026-03-12 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 3.1.21 | In distribution | |
| 3.47.0.0. | In distribution | |
| 3.43.0.0 | In distribution | |
| 3.41.0.0 | In distribution | |
| 3.44.0.0 | In distribution | |
| 3.46.0.0. | In distribution | |
| 3.1.20. | In distribution | |
| 3.40.0.0 | In distribution | |
| 3.45.0.0 | In distribution | |
| 3.42.0.0 | In distribution | |
| 3.1.24 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Welch Allyn, Inc. | Welch Allyn, Inc. | 501 |
| SmartLinx Vitals Plus | Philips North America LLC | 174 |
| Norav 1200 Series PC-ECG | Norav Medical Inc. | 154 |
| Capsule Vitals Plus | Philips North America LLC | 64 |
| Iradimed | Iradimed Corporation | 59 |
| Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | GE Medical Systems Information Technologies, Inc. | 44 |
| Medrad® Veris™ 8600 Vital Signs Monitor | Bayer Medical Care Inc. | 26 |
| Xper Flex Cardio Physiomonitoring System | Philips DS North America LLC | 24 |
| Wvsm Wireless Vital Signs Monitor | Athena GTX | 23 |
| 740 Select | ZOE Medical, Inc. | 20 |
| Wvsm Pro, Wireless Vital Signs Monitor Professional | Athena GTX | 20 |
| BioStamp nPoint™ | Medidata Solutions, Inc. | 19 |
Showing 12 of 314. All products under Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K143304 | 2015-05-26 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.