P.O. Vox

FDA 510(k) K860993 · Bloomfield Research and Development, Inc.

Substantially Equivalent

510(k) numberK860993

Submission

Device name
P.O. Vox
Applicant
Bloomfield Research and Development, Inc.
Hilton Head, SC, US
Received
March 17, 1986
Decision date
April 25, 1986
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
ESE – Larynx, Artificial (Battery-Powered)
Device class
Class I (low risk)
Regulation
21 CFR 874.3375
Specialty
Ear, Nose, Throat

Other 510(k)s with product code ESE

510(k)DeviceApplicantDecision
K934483Nu-Vois Battery Powered Artificial LarynxESE · Traditional Mountain Precision Mfg. Ltd. Co.03/16/1994SE
K931371Denrick Speech Aid (DR-1)ESE · Traditional Denrick Corp.08/25/1993SE
K923648Lectro-LarynxESE · Traditional Bruce Medical Supply04/07/1993SE
K914816American Artificial LarynxESE · Traditional Ultravoice, Ltd.02/12/1993SE
K901503Addvox Bone Conductor Amplifier Speaker SystemESE · Traditional Stanton Magnetics, Inc.06/28/1990SE
K860992Vox CompanionESE · Traditional Bloomfield Research and Development, Inc.05/02/1986SE
K854158Resnick Emitter, Artificial LarynxESE · Traditional Dynamed Audio, Inc.12/13/1985SE
K840892Electro-PalateESE · Traditional Cisko Systems05/22/1984SE
K834555Bear Venti--VoiceESE · Traditional Bear Medical Systems, Inc.01/24/1984SE
K834522Venti-Voice Nasal CatheterESE · Traditional Respiratory Support Products, Inc.01/17/1984SE

More from Respiratory Support Products, Inc.

510(k)DeviceDecision
K860994Decitel AusculscopeDQD · Traditional 11/07/1986SE
K860992Vox CompanionESE · Traditional 05/02/1986SE

Questions and answers

When was P.O. Vox cleared by the FDA?

P.O. Vox (K860993) received a 510(k) decision of Substantially Equivalent on April 25, 1986, 39 days after the submission was received.

What is the product code of K860993?

The FDA product code is ESE – Larynx, Artificial (Battery-Powered), a Class I (low risk) device regulated under 21 CFR 874.3375.