OSTOM-I ALERT— 510(k) K140938

Name: FDA 510(k) clearance K140938
Creator: U.S. Food and Drug Administration
Published: 2014-10-10

Substantially Equivalent

11 Health and Technologies, LLC

FDA 510(k) clearance K140938 for OSTOM-I ALERT, Substantially Equivalent on 2014-10-10. Applicant: 11 Health and Technologies, LLC. Device class: 1.

Clearance details

Applicant: 11 Health and Technologies, LLC
Product code: Code EXB
Device class: Class 1
Regulation: 21 CFR 876.5900
Advisory panel: Gastroenterology, Urology
Date received: 2014-04-11
Decision date: 2014-10-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Crofton, MD, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code EXB

product code EXB

Injury: 145
Total: 145

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.