AMERICAN ARTIFICIAL LARYNX— 510(k) K914816

Substantially Equivalent

Ultravoice, Ltd.

FDA 510(k) clearance K914816 for AMERICAN ARTIFICIAL LARYNX, Substantially Equivalent on 1993-02-12. Applicant: Ultravoice, Ltd.. Device class: 1.

Clearance details

Applicant: Ultravoice, Ltd.
Product code: Code ESE
Device class: Class 1
Regulation: 21 CFR 874.3375
Advisory panel: Ear, Nose, Throat
Date received: 1991-10-25
Decision date: 1993-02-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Paoli, PA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.