SOLAR GI— 510(k) K052338

Substantially Equivalent

Medical Measurement Systems B.V.

FDA 510(k) clearance K052338 for SOLAR GI, Substantially Equivalent on 2005-12-15. Applicant: Medical Measurement Systems B.V..

Clearance details

Applicant: Medical Measurement Systems B.V.
Product code: Code FFX
Advisory panel: Gastroenterology, Urology
Date received: 2005-08-26
Decision date: 2005-12-15
Decision: Substantially Equivalent
Clearance type: Special
Location: Enschede Overijssel, NL

Download summary PDF View on FDA.gov ↗

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.