COMPASS ESOPHAGEAL PRESSURE CATHETER, MODEL GIE-8500, COMPASS ANO-RECTAL PRESSURE CATHETER, MODEL GIA-8500


Device Classification Name

monitor, esophageal motility, and tube

510(k) Number K022023
Device Name COMPASS ESOPHAGEAL PRESSURE CATHETER, MODEL GIE-8500, COMPASS ANO-RECTAL PRESSURE CATHETER, MODEL GIA-8500
Original Applicant
CLINICAL INNOVATIONS, INC.
747 west 4170 south
murray, 
UT 
84123

Original Contact william dean wallace
Regulation Number 876.1725
Classification Product Code
KLA  
Date Received 06/20/2002
Decision Date 01/07/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No