510(k) K090406
K090406 is an FDA 510(k) premarket notification submitted by Interacoustics AS for the device "EP15 SOFTWARE MODULE, EP25 SOFTWARE MODULE". The FDA issued a decision of Substantially Equivalent on July 22, 2009. The device falls under product code EWO (Audiometer), a Class II device regulated under 21 CFR 874.1050. Interacoustics AS has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 22, 2009
- Date Received
- February 17, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Audiometer
- Device Class
- Class II
- Regulation Number
- 874.1050
- Review Panel
- EN
- Submission Type