SOUNDTEK MODEL UT-4700— 510(k) K864766

Substantially Equivalent

Soundtek, Inc.

FDA 510(k) clearance K864766 for SOUNDTEK MODEL UT-4700, Substantially Equivalent on 1987-03-12. Applicant: Soundtek, Inc.. Device class: 2.

Clearance details

Applicant: Soundtek, Inc.
Product code: Code IMJ
Device class: Class 2
Regulation: 21 CFR 890.5290
Advisory panel: Physical Medicine
Date received: 1986-12-05
Decision date: 1987-03-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Geneva, IL, 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.