Medical Device Manufacturer · AU , Brisbane, Queensland

Impedimed Pty , Ltd. - FDA 510(k) Cleared Devices

4 submissions · 2 cleared · Since 2005

Recent clearances: IMPEDIMED EXTRA CELLULAR FLUID ANALYSIS, MODEL L-DEX U400, IMPEDIMED-EXTRACELLULAR FLUID ANALYSIS, IMPEDIMED - BODY COMPOSITION ANALYZER, MODEL IMP SFB7

4

Total

2

Cleared

0

Denied

FDA 510(k) Regulatory Record - Impedimed Pty , Ltd. Gastroenterology & Urology ✕

4 devices

1-4 of 4

Cleared Oct 03, 2008

IMPEDIMED EXTRA CELLULAR FLUID ANALYSIS, MODEL L-DEX U400

Gastroenterology & Urology · 193d

Cleared Mar 30, 2007

IMPEDIMED-EXTRACELLULAR FLUID ANALYSIS

Gastroenterology & Urology · 770d

Cleared Apr 04, 2006

IMPEDIMED - BODY COMPOSITION ANALYZER, MODEL IMP SFB7

Gastroenterology & Urology · 222d

Cleared Jul 13, 2005

IMPEDIMED - BODY COMPOSITION ANALYSIS

Gastroenterology & Urology · 147d