← Back to catalogue

Sickbay Clinical Platform

FDA UDI

Class II (US FDA UDI)

by Medical Informatics Corp

Identity

Trade Name
Sickbay Clinical Platform FDA UDI
Generic Name
Medical equipment clinical data interfacing software FDA UDI
Device Name
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. FDA UDI
Model / Reference
3.1.20. FDA UDI
Description
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. FDA UDI

Identifiers

Primary DI / UDI-DI
B693SICKBAY0301200 FDA UDI
510(k) Number
K143304 FDA UDI
FDA Product Code
MWI FDA UDI
GMDN Term
Medical equipment clinical data interfacing software FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.2300 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Safe FDA UDI

Category: Medical equipment clinical data interfacing software

Sickbay Clinical Platform by Medical Informatics Corp — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Medical equipment clinical data interfacing software.

Cleared under the same submission

K143304 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Medical Informatics Corp

Sources (1)

  • FDA UDI 1295b2b0-fc71-4fef-bf83-e86806afe7ed 34 fields · synced May 31, 2026