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510(k) K931371

DENRICK SPEECH AID (DR-1) by Denrick Corp. — Product Code ESE

K931371 is an FDA 510(k) premarket notification submitted by Denrick Corp. for the device "DENRICK SPEECH AID (DR-1)". The FDA issued a decision of Substantially Equivalent on August 25, 1993. 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
August 25, 1993
Date Received
March 17, 1993
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)
  • 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)
  • 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)

FDA data resources