Cleared Traditional

K011471 - BILITEC 2000, POLYGRAM '98 PH TESTING APPLICATION (INCL.BILE), OPTICAL FIBER PROBER
(FDA 510(k) Clearance)

K011471 · Medtronic Functional Diagnostics A/S · Gastroenterology & Urology device

Nov 2002

Decision

543d

Days

Class 2

Risk

K011471 is an FDA 510(k) clearance for the BILITEC 2000, POLYGRAM '98 PH TESTING APPLICATION (INCL.BILE), OPTICAL FIBER PROBER. 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 November 8, 2002, 543 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	K011471 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	May 14, 2001
Decision Date	November 08, 2002
Days to Decision	543 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	Summary PDF