Cleared Traditional

K942247 - SMALL BOWEL ANALYSIS SOFTWARE
(FDA 510(k) Clearance)

K942247 · Sandhill Scientific, Inc. · Gastroenterology & Urology device

Apr 1996

Decision

701d

Days

Class 2

Risk

K942247 is an FDA 510(k) clearance for the SMALL BOWEL ANALYSIS SOFTWARE. This device is classified as a System, Gastrointestinal Motility (electrical) (Class II - Special Controls, product code FFX).

Submitted by Sandhill Scientific, Inc. (Littleton, US). The FDA issued a Cleared decision on April 9, 1996, 701 days after receiving the submission on May 9, 1994.

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

Submission Details

510(k) Number	K942247 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	May 09, 1994
Decision Date	April 09, 1996
Days to Decision	701 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	Summary PDF