BAROSTAT SOFTWARE OPTION— 510(k) K120997

Name: FDA 510(k) clearance K120997
Creator: U.S. Food and Drug Administration
Published: 2012-08-27

Substantially Equivalent

Crospon, Ltd.

FDA 510(k) clearance K120997 for BAROSTAT SOFTWARE OPTION, Substantially Equivalent on 2012-08-27. Applicant: Crospon, Ltd.. Device class: 2.

Clearance details

Applicant: Crospon, Ltd.
Product code: Code FFX
Device class: Class 2
Regulation: 21 CFR 876.1725
Advisory panel: Gastroenterology, Urology
Date received: 2012-04-02
Decision date: 2012-08-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bonita Springs, FL, US

Download summary PDF View on FDA.gov ↗

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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.