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510(k) K854158

RESNICK EMITTER, ARTIFICIAL LARYNX by Dynamed Audio, Inc. — Product Code ESE

K854158 is an FDA 510(k) premarket notification submitted by Dynamed Audio, Inc. for the device "RESNICK EMITTER, ARTIFICIAL LARYNX". The FDA issued a decision of Substantially Equivalent on December 13, 1985. The device falls under product code ESE (Larynx, Artificial (Battery-Powered)), a Class I device regulated under 21 CFR 874.3375.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 13, 1985
Date Received
October 11, 1985
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)
  • K914816 — AMERICAN ARTIFICIAL LARYNX (February 12, 1993)
  • K901503 — ADDVOX BONE CONDUCTOR AMPLIFIER SPEAKER SYSTEM (June 28, 1990)
  • K860992 — VOX COMPANION (May 2, 1986)
  • K860993 — P.O. VOX (April 25, 1986)
  • K840892 — ELECTRO-PALATE (May 22, 1984)
  • K834555 — BEAR VENTI--VOICE (January 24, 1984)
  • K834522 — VENTI-VOICE NASAL CATHETER (January 17, 1984)

FDA data resources