Company · US

Datrix

FDA 510(k) clearances and medical device recalls filed under this name, 1992 to 2005. Name variants (Inc, Corp, punctuation) are merged.

5510(k) clearances (0 in 12 months)

0recalls (0 in 12 months)

0recalls that name a 510(k)

Product codes

Code	Device	Records
MWJ	Electrocardiograph, Ambulatory (Without Analysis)	2
DPS	Electrocardiograph	1
DQK	Computer, Diagnostic, Programmable	1
DSH	Recorder, Magnetic Tape, Medical	1

Decided	510(k)	Device and applicant	Code
Nov 30, 2005	K053083	DATRIX CARDIO WIFI ELECTROCARDIOGRAPH Datrix	DPS
Nov 1, 2005	K052883	CARDIOSERVER Datrix	DQK
Oct 15, 2003	K031074	DIGITAL AMBULATORY ECG (HOLTER) RECORDER Datrix	MWJ
Nov 10, 1998	K982975	DIGITAL ECG HOLTER RECORDER, MODEL DR512 Datrix	MWJ
Mar 30, 1992	K921068	GIKTER ECG CASSETTE TAPE RECORDER MODEL XR 300 Datrix	DSH

Date	Firm and product	Code	Linked 510(k)
No recalls in this window.