Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015437214

FEI Number

3015437214

Entity Name

INTEGO SOFTWARE, LLC D/B/A CRITICAL ALERT

City/State/Country

Jacksonville, FL, US

Establishment Address

8301 Cypress Plaza Dr Ste 109, Jacksonville, FL 32256, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Intego Software, LLC d/b/a Critical Alert (Owner Number: 10060139)

Owner / Operator Contact Address

8301 Cypress Plaza Drive Ste 109, Jacksonville, FL 32256, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K243270

PMA Number

N/A

All Registered Proprietary Names

CommonPath TigerConnect Alarm Management

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ILQ	System, Communication, Powered	Physical Medicine	Class 2	890.3710	2019-04-06
PHC	Infusion Safety Management Software	General Hospital	Class 2	880.5725	2025-11-18
MSX	System, Network And Communication, Physiological Monitors	Cardiovascular	Class 2	870.2300	2025-11-18

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Intego Software, LLC d/b/a Critical Alert

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K973527	Data Critical Corp.	CARDIO-PAGER SYSTEM	1998-03-31
K182637	Philips Medizin Systeme Boeblingen GmbH	Philips IntelliVue XDS Software	2019-04-26

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0004-2016	Lifeline Systems, Incorporated	2	Philips GoSafe Mobile Help Button; 7000MHB. Personal Emergency Response System.
Z-0002-2023	Fresenius Kabi USA, LLC	2	Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004 version 5.2.0

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3007275470	JABBLA	Gent Oost-Vlaanderen, BE
3007883990	SMARTBOX US	Cedar Falls, IA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015437214. Last updated year: 2026. Please use registration number 3015437214 when referencing this establishment in official correspondence.