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FDA 510(k)

VOX COMPANION

K-Number: K860992 · 1986-05-02

ApplicantBloomfield Research and Development, Inc.
Decision Date1986-05-02
Product CodeESE
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

VOX COMPANION is the device name listed in this FDA 510(k) record. The listed applicant is Bloomfield Research and Development, Inc.. It received FDA 510(k) clearance on 1986-05-02 under 510(k) number K860992. The device is classified under product code ESE. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VOX COMPANION?

VOX COMPANION is a medical device that received FDA 510(k) clearance on 1986-05-02. The listed applicant is Bloomfield Research and Development, Inc.. The 510(k) number is K860992.

When did VOX COMPANION receive FDA 510(k) clearance?

VOX COMPANION received FDA 510(k) clearance on 1986-05-02, under 510(k) number K860992.

Who is the listed applicant for VOX COMPANION?

The FDA 510(k) record lists Bloomfield Research and Development, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VOX COMPANION?

The FDA product code for VOX COMPANION is ESE.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Bloomfield Research and Development, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K860994DECITEL AUSCULSCOPEK860993P.O. VOX

Related Devices (Code: ESE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K934483NU-VOIS BATTERY POWERED ARTIFICIAL LARYNXMountain Precision Mfg. Ltd. Co.K931371DENRICK SPEECH AID (DR-1)Denrick Corp.K923648LECTRO-LARYNXBruce Medical SupplyK914816AMERICAN ARTIFICIAL LARYNXUltravoice, Ltd.K901503ADDVOX BONE CONDUCTOR AMPLIFIER SPEAKER SYSTEMStanton Magnetics, Inc.K860993P.O. VOXBloomfield Research and Development, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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