Cleared Traditional

K014269 - POLYGRAM NET ELECTROGASTROGRAPHY APPLICATION SOFTWARE, MODEL 9043S0151; POLYGRAF ID, MODEL 9043G0102
(FDA 510(k) Clearance)

K014269 · Medtronic Functional Diagnostics A/S · Gastroenterology & Urology device

Nov 2002

Decision

329d

Days

Class 2

Risk

K014269 is an FDA 510(k) clearance for the POLYGRAM NET ELECTROGASTROGRAPHY APPLICATION SOFTWARE, MODEL 9043S0151; POLYGRAF ID, MODEL 9043G0102. This device is classified as a System, Electrogastrography (egg) (Class II - Special Controls, product code MYE).

Submitted by Medtronic Functional Diagnostics A/S (Skovlunde, DK). The FDA issued a Cleared decision on November 21, 2002, 329 days after receiving the submission on December 27, 2001.

This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1735.

Submission Details

510(k) Number	K014269 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 27, 2001
Decision Date	November 21, 2002
Days to Decision	329 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	Summary PDF