BIOFEEDBACK SYSTEM FOR SPEECH DISORDERS— 510(k) K942651

Name: FDA 510(k) clearance K942651
Creator: U.S. Food and Drug Administration
Published: 1995-10-19

Substantially Equivalent

Casa Futura Technologies

FDA 510(k) clearance K942651 for BIOFEEDBACK SYSTEM FOR SPEECH DISORDERS, Substantially Equivalent on 1995-10-19. Applicant: Casa Futura Technologies. Device class: 1.

Clearance details

Applicant: Casa Futura Technologies
Product code: Code KTH
Device class: Class 1
Regulation: 21 CFR 874.5840
Advisory panel: Ear, Nose, Throat
Date received: 1994-06-03
Decision date: 1995-10-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Monte Sereno, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KTH

view all

K962961 — SUSTAINED PHONATION1996-09-09
K871590 — VOCALTECH VOCAL FEEDBACK DEVICE1987-10-06
K800445 — EDINBURGH MASKER1980-03-12

Data sourced from openFDA. This site is unofficial and independent of the FDA.