510(k) K090601— FSC 2

Substantially Equivalent

Schoelly Imaging, Inc.

Clearance details

Applicant: Schoelly Imaging, Inc.
Product code: Code NTN
Advisory panel: Gastroenterology, Urology
Date received: 2009-03-05
Decision date: 2009-05-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Boylston, MA, US

Adverse events under product code NTN

product code NTN

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.