VOX COMPANION— 510(k) K860992

Name: FDA 510(k) clearance K860992
Creator: U.S. Food and Drug Administration
Published: 1986-05-02

Substantially Equivalent

Bloomfield Research and Development, Inc.

FDA 510(k) clearance K860992 for VOX COMPANION, Substantially Equivalent on 1986-05-02. Applicant: Bloomfield Research and Development, Inc.. Device class: 1.

Clearance details

Applicant: Bloomfield Research and Development, Inc.
Product code: Code ESE
Device class: Class 1
Regulation: 21 CFR 874.3375
Advisory panel: Ear, Nose, Throat
Date received: 1986-03-17
Decision date: 1986-05-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hilton Head, SC, US

Download summary PDF View on FDA.gov ↗

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