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510(k) K831127

INTRA-ORAL ARTIFICIAL LARYNX by Xomed, Inc. — Product Code ESE

K831127 is an FDA 510(k) premarket notification submitted by Xomed, Inc. for the device "INTRA-ORAL ARTIFICIAL LARYNX". The FDA issued a decision of Substantially Equivalent on July 28, 1983. The device falls under product code ESE (Larynx, Artificial (Battery-Powered)), a Class I device regulated under 21 CFR 874.3375. Xomed, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 28, 1983
Date Received
April 6, 1983
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 by Xomed, Inc.

  • K002395 — MODEL 30 CLASSIC PNEUMATONOMETER (December 11, 2000)
  • K002987 — REDTRONIC XOMED MONOPOLAR ENERGIZED BLADE (December 4, 2000)
  • K002828 — XPS NITRO SYSTEM (October 17, 2000)
  • K002897 — TITANIUM MIDDLE EAR PROSTHESES (October 11, 2000)
  • K993653 — MICRO-FRANCE TROCARS AND ACCESSORIES (June 9, 2000)
  • K001148 — MEROGEL OTOLOGIC PACK (June 3, 2000)
  • K994262 — FRONTAL SINUS TREPHINATION CANNULA (February 8, 2000)
  • K992855 — XPS STRAIGHTSHOT OR MODEL 2000 MICRODEBRIDER SYSTEM OR XPS POWERSCULPT (January 21, 2000)
  • K993582 — MODIFICATION TO LASER-SHIELD II (January 20, 2000)
  • K993655 — MICRO-FRANCE ELECTROSURGICAL INSTRUMENTS, VARIOUS (December 21, 1999)

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)
  • K854158 — RESNICK EMITTER, ARTIFICIAL LARYNX (December 13, 1985)
  • K840892 — ELECTRO-PALATE (May 22, 1984)
  • K834555 — BEAR VENTI--VOICE (January 24, 1984)

FDA data resources