Medical Device Manufacturer · US , Ithaca , NY

Transonic Systems, Inc. - FDA 510(k) Cleared Devices

16 submissions · 16 cleared · Since 1988

16

Total

16

Cleared

0

Denied

FDA 510(k) Regulatory Record - Transonic Systems, Inc. Gastroenterology & Urology ✕

5 devices

1-5 of 5

Cleared Dec 04, 2002

TRANSONIC SYRINGE WARMER, MODEL SYR-1000

Gastroenterology & Urology · 89d

Cleared Aug 12, 2002

TRANSONIC FLOW-QC SET MODEL ADT1010

Gastroenterology & Urology · 90d

Cleared Nov 22, 2000

TRANSONIC HEMODIALYSIS FLOW REVERSER, MODEL B FLOWREV

Gastroenterology & Urology · 72d

Cleared Oct 06, 1998

TRANSONIC HEMODIALYSIS MONITOR, CARDIAC OUTPUT, MODEL HD01-CO

Gastroenterology & Urology · 210d

Cleared Feb 11, 1997

HD01-SERIES TRANSONIC HEMODIALYSIS MONITOR (R%,QA,CO,QB,QB2)

Gastroenterology & Urology · 349d