Medical Device Manufacturer · US , Miami Beach , FL

Galix Biomedical Instrumentation, Inc. - FDA 510(k) Cleared Devices

6 submissions · 6 cleared · Since 1998

6

Total

6

Cleared

0

Denied

FDA 510(k) Regulatory Record - Galix Biomedical Instrumentation, Inc. Cardiovascular ✕

6 devices

1-6 of 6

Cleared Jul 09, 2010

3 CHANNEL DIGITAL AMBULATORY ECG RECORDER MODEL GALIX GBI-3SM

Cardiovascular · 296d

Cleared Jan 31, 2006

GALIX ECG PROFESSIONAL STATION

Cardiovascular · 271d

Cleared Sep 17, 2003

Cardiovascular · 245d

Cleared Jun 11, 2003

Cardiovascular · 267d

Cleared Mar 15, 2001

GALIX GBI -3S-LP

Cardiovascular · 581d

Cleared Jan 29, 1998

3 CHANNEL DIGITAL AMBULATORY ECG RECORDER

Cardiovascular · 268d