UltraClot, UltraClot OTC— 510(k) K082601
Substantially EquivalentEmergency Medical Devices, LLC
FDA 510(k) clearance K082601 for UltraClot, UltraClot OTC, Substantially Equivalent on 2008-10-09. Applicant: Emergency Medical Devices, LLC.
Clearance details
- Applicant
- Emergency Medical Devices, LLC
- Product code
- Code QSY
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Wellington, FL, US
Adverse events under product code QSY
product code QSY- Death
- 5
- Other
- 1
- Total
- 6
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.