510(k) K151025
K151025 is an FDA 510(k) premarket notification submitted by Ihear Medical, Inc. for the device "iHearTest". The FDA issued a decision of Substantially Equivalent on December 29, 2015. 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
- December 29, 2015
- Date Received
- April 16, 2015
- 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