Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014271754

FEI Number

3014271754

Entity Name

ICENTIA Inc

City/State/Country

Quebec, CA

Establishment Address

2750 rue Einstein, Quebec G1P 4R1, CA

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Icentia.com (Owner Number: 10082168)

Owner / Operator Contact Address

2750 rue Einstein, Quebec, CA-QC g1p4r1, CA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K223049

PMA Number

N/A

All Registered Proprietary Names

3M Red Dot OFIX CardioSTAT ECG Test Solution

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DRX	Electrode, Electrocardiograph	Cardiovascular	Class 2	870.2360	2021-06-22
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2021-06-22
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2023-03-23
DSH	Recorder, Magnetic Tape, Medical	Cardiovascular	Class 2	870.2800	2023-03-23

Official Correspondent

No official correspondent registered.

US Agent Details

Josh Baker Email: josh@jbshelp.com Phone: (714) 7888512

Related Public Records

Same Entity

Icentia.com

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
K934333	3M Medical Products Group	3M RED DOT 2237 STICKY GEL MONITORING ECG ELECTRODE	1994-07-07
K843874	Beiersdorf, Inc.	LEUKOPOR SURGICAL TAPE	1985-02-21
K915446	Sun Glitz Corp.	STRETCH WRAP	1992-05-06
K833120	Acme United Corp.	ONE TIME COMPOUND BENZOIN TINCTURE-	1983-12-29
K870091	Avery Intl.	IV SECUREMENT DEVICE USING PCCE THERMO. FILM	1987-02-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2016	Biosense Webster, Inc.	2	Carto 3 EP Navigation System. Electro physiology system which views of the electrical activity of the heart through real-time data on 3-D, color-coded cardiac maps.
Z-0032-05	Siemens Medical Solutions USA, Inc	2	AXIOM Sensis Programmable diagnostic computer, Model number 66 23 974.
Z-0033-05	Siemens Medical Solutions USA, Inc	2	AXIOM Sensis Programmable diagnostic computer, Model number 66 34 633.
Z-0034-05	Siemens Medical Solutions USA, Inc	2	AXIOM Sensis Programmable diagnostic computer, Model number 66 34 641
Z-0035-05	Siemens Medical Solutions USA, Inc	2	AXIOM Sensis Programmable diagnostic computer, Model number 66 34 658

Similar Registrations

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3013522941	JOHNSON MEDTECH LLC	Vandalia, OH, US
3013873578	SHANGHAI YUECHEN MEDICAL SUPPLY CO..LTD.	Shanghai, CN
3003584029	Braemar Manufacturing, LLC	San Diego, CA, US
3017425211	LOHMANN PRECISION DIE CUTTING, LLC	Orange, VA, US
3008773647	CARDIONET, LLC	Phoenix, AZ, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014271754. Last updated year: 2026. Please use registration number 3014271754 when referencing this establishment in official correspondence.