NU-VOIS BATTERY POWERED ARTIFICIAL LARYNX— 510(k) K934483

Name: FDA 510(k) clearance K934483
Creator: U.S. Food and Drug Administration
Published: 1994-03-16

Substantially Equivalent

Mountain Precision Mfg. Ltd. Co.

FDA 510(k) clearance K934483 for NU-VOIS BATTERY POWERED ARTIFICIAL LARYNX, Substantially Equivalent on 1994-03-16. Applicant: Mountain Precision Mfg. Ltd. Co.. Device class: 1.

Clearance details

Applicant: Mountain Precision Mfg. Ltd. Co.
Product code: Code ESE
Device class: Class 1
Regulation: 21 CFR 874.3375
Advisory panel: Ear, Nose, Throat
Date received: 1993-09-14
Decision date: 1994-03-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boise, ID, US

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