Who is the manufacturer of WEARABLE TWENTY-FOUR CHANNEL VIBROTACTILE VOCODER?

Institute of Logopedics filed the 510(k) submission for WEARABLE TWENTY-FOUR CHANNEL VIBROTACTILE VOCODER (K862471).

What is the FDA product code for WEARABLE TWENTY-FOUR CHANNEL VIBROTACTILE VOCODER?

LRA. as a Class U device in the EN panel.

What is the regulatory pathway for WEARABLE TWENTY-FOUR CHANNEL VIBROTACTILE VOCODER?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like WEARABLE TWENTY-FOUR CHANNEL VIBROTACTILE VOCODER?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

WEARABLE TWENTY-FOUR CHANNEL VIBROTACTILE VOCODER

K862471 · Institute of Logopedics · LRA · Sep 12, 1986 · EN

Device Facts

Record ID	K862471
Device Name	WEARABLE TWENTY-FOUR CHANNEL VIBROTACTILE VOCODER
Applicant	Institute of Logopedics
Product Code	LRA · EN
Decision Date	Sep 12, 1986
Decision	SESE
Submission Type	Traditional
Device Class	Class U

WEARABLE TWENTY-FOUR CHANNEL VIBROTACTILE VOCODER

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