SCANO 731B & 731C ULTRASOUND SOFT TIS DEPT MEAS SY— 510(k) K853147
Substantially EquivalentScano, Inc.
FDA 510(k) clearance K853147 for SCANO 731B & 731C ULTRASOUND SOFT TIS DEPT MEAS SY, Substantially Equivalent on 1986-03-13. Applicant: Scano, Inc..
Clearance details
- Applicant
- Scano, Inc.
- Product code
- Code IYO
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Ithaca, NY, US
Adverse events under product code IYO
product code IYO- Malfunction
- 3,339
- Total
- 3,339
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.