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510(k) K860992

VOX COMPANION by Bloomfield Research and Development, Inc. — Product Code ESE

K860992 is an FDA 510(k) premarket notification submitted by Bloomfield Research and Development, Inc. for the device "VOX COMPANION". The FDA issued a decision of Substantially Equivalent on May 2, 1986. The device falls under product code ESE (Larynx, Artificial (Battery-Powered)), a Class I device regulated under 21 CFR 874.3375. Bloomfield Research and Development, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 2, 1986
Date Received
March 17, 1986
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 Bloomfield Research and Development, Inc.

  • K860994 — DECITEL AUSCULSCOPE (November 7, 1986)
  • K860993 — P.O. VOX (April 25, 1986)

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)
  • 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