510(k) K072033
K072033 is an FDA 510(k) premarket notification submitted by Otodynamics, Ltd. for the device "OTODYNAMICS OTOPORT". The FDA issued a decision of Substantially Equivalent on November 13, 2007. 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
- November 13, 2007
- Date Received
- July 24, 2007
- 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