GENESIS II— 510(k) K133434
Substantially EquivalentDornier Medtech America, Inc.
FDA 510(k) clearance K133434 for GENESIS II, Substantially Equivalent on 2014-11-26. Applicant: Dornier Medtech America, Inc..
Clearance details
- Applicant
- Dornier Medtech America, Inc.
- Product code
- Code JAA
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Kennesaw, GA, US
Adverse events under product code JAA
product code JAA- 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.