510(k) K091070— MANOSCAN MOTILITY WITH IMPEDANCE VISUALIZATION SYSTEM
Substantially EquivalentSierra Scientific Instruments, Inc.
Clearance details
- Applicant
- Sierra Scientific Instruments, Inc.
- Product code
- Code FFX
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Los Angeles, CA, US
Adverse events under product code FFX
product code FFX- Other
- 1
- Total
- 1
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.