510(k) K112992
K112992 is an FDA 510(k) premarket notification submitted by Earlogic Corporation for the device "EARLOGIC OAE TESTER". The FDA issued a decision of Substantially Equivalent on April 20, 2012. The device falls under product code EWO (Audiometer), a Class II device regulated under 21 CFR 874.1050.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 20, 2012
- Date Received
- October 6, 2011
- 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