Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2028530

FEI Number

1000125122

Entity Name

Datrix LLC

City/State/Country

Escondido, CA, US

Establishment Address

382 State Pl, Escondido, CA 92029, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Datrix LLC (Owner Number: 10054495)

Owner / Operator Contact Address

382 State pl., Escondido, CA 92029, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K111160

PMA Number

N/A

All Registered Proprietary Names

Sirona CardioHolter AT MyCardia AT GEMS Sirona Sentinel EX1000 Centauri

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MWJ	Electrocardiograph, Ambulatory (Without Analysis)	Cardiovascular	Class 2	870.2800	2017-03-25
DXH	Transmitters And Receivers, Electrocardiograph, Telephone	Cardiovascular	Class 2	870.2920	2017-03-25
DSI	Detector And Alarm, Arrhythmia	Cardiovascular	Class 2	870.1025	2017-03-25

Official Correspondent

Jon Barron

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Datrix LLC

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
K820986	Dart Medical Equipment	EKG MONITORS, VARIOUS MODELS	1982-04-29
K910450	Medtech Industries, Inc.	CARD GUARD-3000 ECG TELEPHONE ADAPTER	1991-05-07
K761318	Cambridge Instruments, Inc.	3038 OPTION B-COMPUT. TRANS. TERMINAL	1977-01-06
K972649	Reynolds Medical , Ltd.	CARDIOCALL CARDIAC EVENT RECORDER	1997-12-04
K033410	Remote Diagnostic Technologies , Ltd.	TEMPUS 2000 PATIENT MONITOR, MODEL 00-0002	2004-03-05

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0007-2025	Philips North America	2	IntelliVue G7m Anesthesia Gas Module, Product Number 866173
Z-0030-05	General Electric Medical Systems Information Technology	2	GE CIC Central Station Monitoring Product, Versions 3.x, 4.0.5, 4.0.6
Z-0034-2011	Philips Medical Systems North America Co. Phillips	2	The device's marketing brochure states: "IntelliVue M3150 Information Center...Philips Medical Systems". The beige-colored PAS-210 external speakers can be identified by their use of DB15-to-3.5 mm mini-phone jack cable (Agispec-081Y-4 or Agispec-081-6) to connect to the rp5700 PC. Indicated for central monitoring of multiple adult, pediatric, and neonatal patients.
Z-0035-2025	Philips North America	2	Patient Information Center iX, Product Code 866386, and Patient Information Center iX Expand, Product Code 866390, Software Revision 4.0.1

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3004006614	GETEMED MEDIZIN- UND INFORMATIONSTECHNIK AG	TELTOW Brandenburg, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2028530. Last updated year: 2026. Please use registration number 2028530 when referencing this establishment in official correspondence.