510(k) K862471
K862471 is an FDA 510(k) premarket notification submitted by Institute of Logopedics for the device "WEARABLE TWENTY-FOUR CHANNEL VIBROTACTILE VOCODER". The FDA issued a decision of Substantially Equivalent on September 12, 1986. The device falls under product code LRA (Hearing Aid, Tactile), a Class U device.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 12, 1986
- Date Received
- June 30, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Hearing Aid, Tactile
- Device Class
- Class U
- Regulation Number
- Review Panel
- EN
- Submission Type