Cleared Traditional

K011472 - POLYGRAM 98 ANORECTAL FUNCTION TESTING APPLICATION, POLYGRAM 98 ESOPHAGEAL MANOMETRY APPLICATION, POLYGRAF ID
(FDA 510(k) Clearance)

K011472 · Medtronic Functional Diagnostics A/S · Gastroenterology & Urology device

Aug 2001

Decision

88d

Days

Class 2

Risk

K011472 is an FDA 510(k) clearance for the POLYGRAM 98 ANORECTAL FUNCTION TESTING APPLICATION, POLYGRAM 98 ESOPHAGEAL MANOMETRY APPLICATION, POLYGRAF ID. This device is classified as a System, Gastrointestinal Motility (electrical) (Class II - Special Controls, product code FFX).

Submitted by Medtronic Functional Diagnostics A/S (Skovlunde, DK). The FDA issued a Cleared decision on August 10, 2001, 88 days after receiving the submission on May 14, 2001.

This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1725.

Submission Details

510(k) Number	K011472 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	May 14, 2001
Decision Date	August 10, 2001
Days to Decision	88 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	Summary PDF