510(k) K052562
K052562 is an FDA 510(k) premarket notification submitted by Interacoustics AS for the device "ECLIPSE (CABINET NAME), TEOAE25, EP15, OR THE COMBINATION OF SYSTEMS.". The FDA issued a decision of Substantially Equivalent on December 23, 2005. 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
- December 23, 2005
- Date Received
- September 19, 2005
- 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