Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017374019

FEI Number

3017374019

Entity Name

AVERTIX MEDICAL INC.

City/State/Country

Eatontown, NJ, US

Establishment Address

40 Christopher Way, Suite 201, Eatontown, NJ 07724, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Complaint File Establishment per 21 CFR 820.198

Owner / Operator

Avertix Medical Inc. (Owner Number: 10079576)

Owner / Operator Contact Address

40 Christopher Way, Suite 201, Eatontown, NJ 07724, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

P150009

All Registered Proprietary Names

The Guardian System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QBI	Acute Coronary Syndrome Event Detector	Unknown	Class 3	N/A	2020-12-14

Official Correspondent

David Keenan

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Avertix Medical Inc.

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017374019. Last updated year: 2026. Please use registration number 3017374019 when referencing this establishment in official correspondence.