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Sickbay Clinical Platform

FDA 510(k)FDA UDI

Class II (US FDA 510(k))

510(k) K143304

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 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 data in real-time when gathered or at a later time. FDA UDI
Model / Reference
3.43.0.0 FDA UDI
Description
Sickbay Clinical Platform is a software product that is intended to run 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 data in real-time when gathered or at a later time. FDA UDI

Identifiers

Primary DI / UDI-DI
B693SICKBAY034300 FDA UDI
510(k) Number
K143304 FDA 510(k)FDA UDI
FDA Product Code
MWI FDA 510(k)FDA UDI
GMDN Term
Medical equipment clinical data interfacing software FDA UDI

Classification

Device Class
Class II FDA 510(k)FDA UDI
Legislation / Framework
21 CFR Part 870.2300 FDA 510(k)
Regulation Number
870.2300 FDA 510(k)FDA UDI
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)
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

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sickbay Clinical Platform by Medical Informatics Corp — Class II — FDA_510K — listed in FDA 510(k), FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Medical Informatics Corp

Sources (2)

  • FDA 510(k) K143304 24 fields · synced Jun 18, 2026
  • FDA UDI 1916f4f4-69ef-427f-b012-2fc617ec723c 34 fields · synced May 27, 2026