K860697
Substantially Equivalent for Some IndicationsULTRASOUND IMAGING SYSTEM MODEL 280 SL
- Applicant
- Johnson & Johnson Professionals, Inc.
- Product code
- IYO
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent for Some Indications
- Clearance type
- Traditional
- Location
- Ramsey, NJ, 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.