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510(k) K901503

ADDVOX BONE CONDUCTOR AMPLIFIER SPEAKER SYSTEM by Stanton Magnetics, Inc. — Product Code ESE

K901503 is an FDA 510(k) premarket notification submitted by Stanton Magnetics, Inc. for the device "ADDVOX BONE CONDUCTOR AMPLIFIER SPEAKER SYSTEM". The FDA issued a decision of Substantially Equivalent on June 28, 1990. 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
June 28, 1990
Date Received
March 30, 1990
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)
  • 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