GAELTEC MPR SERIES

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MOTILITY PROBE MODEL NUMBERS P31 THRU P38, P40 THRU P43 AND P50

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

POLYGRAF ID, POLYGRAM '98 ESOPHAGEAL MANOMETRY TESTING APPLICATION, MODELS 9043G0121-9043G0151, 9043S0101

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

GASTRIC AND RECTAL CATHETERS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ENDOFLIP CATHETER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MICROINFUSOR

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ESOPHAGEAL MOTILITY APPARATUS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

POLYGRAM 98 ANORECTAL FUNCTION TESTING APPLICATION, MODEL 9043S0111

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MARK II/MARK III MANOMETRIC PERFUSION PUMP

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

BILITEC 2000, POLYGRAM '98 PH TESTING APPLICATION (INCL.BILE), OPTICAL FIBER PROBER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MARK II CO2 FLUSH MANOMETRIC PERFUSION PUMP & MARK II MANOMETRIC PERFUSION PUMP

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

UNITIP GASTROINTESTINAL PRESSURE SENSOR CATHETER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PHTIP DISPOSABLE ISFET CATHETER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ANORECTAL MANOMETRY ANALYSIS MODULE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MOTILITY VISUALIZATION SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

INSIGHT GASTROINTESTINAL MOTILITY SYSTEM, MODEL S980000

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ManoScan System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

DISTENDER SERIES II BAROSTAT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Lehman Manometry Catheter

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SMALL BOWEL ANALYSIS SOFTWARE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology