DISTENDER SERIES II BAROSTAT— 510(k) K991288

Substantially Equivalent

G & J Electronics, Inc.

FDA 510(k) clearance K991288 for DISTENDER SERIES II BAROSTAT, Substantially Equivalent on 1999-06-08. Applicant: G & J Electronics, Inc..

Clearance details

Applicant: G & J Electronics, Inc.
Product code: Code FFX
Advisory panel: Gastroenterology, Urology
Date received: 1999-04-14
Decision date: 1999-06-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Toronto, Ontario, CA

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.