POLYGRAM 98 ANORECTAL FUNCTION TESTING APPLICATION, POLYGRAM 98 ESOPHAGEAL MANOMETRY APPLICATION, POLYGRAF ID


Device Classification Name

system, gastrointestinal motility (electrical)

510(k) Number K011472
Device Name POLYGRAM 98 ANORECTAL FUNCTION TESTING APPLICATION, POLYGRAM 98 ESOPHAGEAL MANOMETRY APPLICATION, POLYGRAF ID
Original Applicant
MEDTRONIC FUNCTIONAL DIAGNOSTICS A/S
16-18 tonsbakken
skovlunde, 

DK

dk-2740

Original Contact tove kjaer
Regulation Number 876.1725
Classification Product Code
FFX  
Date Received 05/14/2001
Decision Date 08/10/2001
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

Type Traditional
Reviewed by Third Party No

Combination Product

No