Home / 510(k) Clearances / K914816

510(k) K914816

AMERICAN ARTIFICIAL LARYNX by Ultravoice, Ltd. — Product Code ESE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 12, 1993
Date Received
October 25, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Larynx, Artificial (Battery-Powered)
Device Class
Class I
Regulation Number
874.3375
Review Panel
EN
Submission Type

Other clearances for product code ESE

  • K934483 — NU-VOIS BATTERY POWERED ARTIFICIAL LARYNX (March 16, 1994)
  • K931371 — DENRICK SPEECH AID (DR-1) (August 25, 1993)
  • K923648 — LECTRO-LARYNX (April 7, 1993)
  • K901503 — ADDVOX BONE CONDUCTOR AMPLIFIER SPEAKER SYSTEM (June 28, 1990)
  • K860992 — VOX COMPANION (May 2, 1986)
  • K860993 — P.O. VOX (April 25, 1986)
  • K854158 — RESNICK EMITTER, ARTIFICIAL LARYNX (December 13, 1985)
  • K840892 — ELECTRO-PALATE (May 22, 1984)
  • K834555 — BEAR VENTI--VOICE (January 24, 1984)
  • K834522 — VENTI-VOICE NASAL CATHETER (January 17, 1984)