OSTOM-I ALERT— 510(k) K140938
Substantially Equivalent11 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.
Clearance details
- Applicant
- 11 Health and Technologies, LLC
- Product code
- Code EXB
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Crofton, MD, US
Adverse events under product code EXB
product code EXB- Injury
- 145
- Total
- 145
Source: openFDA MAUDE database, through . 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.