Medical Device Manufacturer · US , Escondido , CA

Datrix - FDA 510(k) Cleared Devices

5 submissions · 5 cleared · Since 1992

5

Total

5

Cleared

0

Denied

FDA 510(k) Regulatory Record - Datrix Cardiovascular ✕

5 devices

1-5 of 5

Cleared Nov 30, 2005

DATRIX CARDIO WIFI ELECTROCARDIOGRAPH

Cardiovascular · 28d

Cleared Nov 01, 2005

Cardiovascular · 19d

Cleared Oct 15, 2003

DIGITAL AMBULATORY ECG (HOLTER) RECORDER

Cardiovascular · 194d

Cleared Nov 10, 1998

DIGITAL ECG HOLTER RECORDER, MODEL DR512

Cardiovascular · 76d

Cleared Mar 30, 1992

GIKTER ECG CASSETTE TAPE RECORDER MODEL XR 300

Cardiovascular · 24d