EP15 SOFTWARE MODULE, EP25 SOFTWARE MODULE— 510(k) K090406
Substantially EquivalentInteracoustics AS
FDA 510(k) clearance K090406 for EP15 SOFTWARE MODULE, EP25 SOFTWARE MODULE, Substantially Equivalent on 2009-07-22. Applicant: Interacoustics AS. Device class: 2.
Clearance details
- Applicant
- Interacoustics AS
- Product code
- Code EWO
- Device class
- Class 2
- Regulation
- 21 CFR 874.1050
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Assens, DK
Recent devices under product code EWO
view allMore clearances from Interacoustics AS
view allAdverse events under product code EWO
product code EWO- Other
- 2
- Total
- 2
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.