510(k) K143395
K143395 is an FDA 510(k) premarket notification submitted by Otodynamics, Ltd. for the device "Otoport OAE +ABR Advance, Otoport OAE+ABR DP+TE, Otoport OAE+ABR Screener-Otocheck OAE+ABR, Otocheck OAE+ABR LE, Otocheck ABR Screener-Otodynamics ABR Upgrade Kit". The FDA issued a decision of Substantially Equivalent on February 23, 2015. The device falls under product code EWO (Audiometer), a Class II device regulated under 21 CFR 874.1050. Otodynamics, Ltd. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 23, 2015
- Date Received
- November 26, 2014
- 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