510(k) K862471

WEARABLE TWENTY-FOUR CHANNEL VIBROTACTILE VOCODER by Institute of Logopedics — Product Code LRA

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