SMALL BOWEL ANALYSIS SOFTWARE— 510(k) K942247

Substantially Equivalent

Sandhill Scientific, Inc.

FDA 510(k) clearance K942247 for SMALL BOWEL ANALYSIS SOFTWARE, Substantially Equivalent on 1996-04-09. Applicant: Sandhill Scientific, Inc..

Clearance details

Applicant: Sandhill Scientific, Inc.
Product code: Code FFX
Advisory panel: Gastroenterology, Urology
Date received: 1994-05-09
Decision date: 1996-04-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Littleton, CO, US

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Adverse events under product code FFX

product code FFX

Other: 1
Total: 1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.