BioDashboard

FDA UDI

Class II (US FDA UDI)

by Biointellisense, Inc.

Identity

Trade Name: BioDashboard FDA UDI
Generic Name: Clinical management support software FDA UDI
Device Name: BioDashboard, as part of the FDA-cleared BioButton System, is intended to display and visualize physiological and medical data and log assessments. The Device displays data and notifies healthcare professionals when physiological data fall outside clinician specified parameters. The data from the Device are intended as an aid to diagnosis, diseases management, and treatment. The Device has the ability to allow the clinician to configure the parameters for notifications. Healthcare professionals are the intended operators of this device. The Device is intended for use on patients who are 18 years of age or older. The Device is not intended for critical care. FDA UDI
Model / Reference: SW-BDB FDA UDI
Description: BioDashboard, as part of the FDA-cleared BioButton System, is intended to display and visualize physiological and medical data and log assessments. The Device displays data and notifies healthcare professionals when physiological data fall outside clinician specified parameters. The data from the Device are intended as an aid to diagnosis, diseases management, and treatment. The Device has the ability to allow the clinician to configure the parameters for notifications. Healthcare professionals are the intended operators of this device. The Device is intended for use on patients who are 18 years of age or older. The Device is not intended for critical care. FDA UDI

Identifiers

Catalog Number: N/A FDA UDI
Primary DI / UDI-DI: 00850005949466 FDA UDI
510(k) Number: K241101 FDA UDI
FDA Product Code: DRG FDA UDI
DRT FDA UDI
GMDN Term: Clinical management support software FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.2910 FDA UDI
870.2300 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Clinical management support software

BioDashboard by Biointellisense, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K241101 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Biointellisense, Inc.

Sources (1)

FDA UDI 333e3cdc-2d31-48c4-948b-5f1a3f88b6fb 36 fields · synced Jun 8, 2026