Data / Medical devices / United States / Datrix LLC
Datrix LLC: FDA-registered device maker in Escondido, CA, United States, 4 510(k) clearances
Datrix LLC is registered with the FDA (registration 2028530) in Escondido, CA, United States. It lists 3 device types. The FDA files 4 510(k) clearances under its listings, the newest dated November 9, 2011. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2028530
- FEI number
- 1000125122
- Address
- 382 State Pl, Escondido, CA, United States, 92029
- Owner or operator
- Datrix LLC (10054495)
- Roles
- Manufacturer, Specification developer
- First device listed
- March 25, 2017
- Registered through
- 2026
- Brand names listed
- CardioHolter AT, Centauri, EX1000, GEMS Sirona, MyCardia AT, Sentinel, Sirona, VX3+
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Detector And Alarm, Arrhythmia | DSI | 2 | Specification developer | accessdata.fda.gov |
| Electrocardiograph, Ambulatory (Without Analysis) | MWJ | 2 | Manufacturer | accessdata.fda.gov |
| Transmitters And Receivers, Electrocardiograph, Telephone | DXH | 2 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 9, 2011 | K112601 | INTRICON DATRIX SIRONA EVENT/ HOLTER RECORDER | MWJ | Substantially Equivalent | Intricon Datrix Corporation | accessdata.fda.gov |
| August 1, 2011 | K111160 | INTRICON DATRIX CENTAURI MT AMBULATORY PATIENT ECG TELEMETRY SYSTEM (APETS) | DSI | Substantially Equivalent | Intricon Datrix Corporation | accessdata.fda.gov |
| August 12, 2004 | K042022 | E-TAC EX-1000 ELECTROCARDIOGRAPHIC EVENT RECORDER | DXH | Substantially Equivalent | Datrix, Inc. Dba of Jon Barron, Inc. | accessdata.fda.gov |
| October 15, 2003 | K031074 | DIGITAL AMBULATORY ECG (HOLTER) RECORDER | MWJ | Substantially Equivalent | Datrix | accessdata.fda.gov |
Compare with other makers
- All makers of Transmitters And Receivers, Electrocardiograph, Telephone
- All makers of Electrocardiograph, Ambulatory (Without Analysis)
- All makers of Detector And Alarm, Arrhythmia
Updated November 9, 2011. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.