510(k) K240430
K240430 is an FDA 510(k) premarket notification submitted by Otodynamics, Ltd. for the device "Otoport Pro". The FDA issued a decision of Substantially Equivalent on March 15, 2024. 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
- March 15, 2024
- Date Received
- February 14, 2024
- Clearance Type
- Special
- 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