DANPLEX DIAGNOSTIC AUDIOMETER, CLIN. DIAG. AUDIOMT— 510(k) K923071

Name: FDA 510(k) clearance K923071
Creator: U.S. Food and Drug Administration
Published: 1992-09-28

Substantially Equivalent

Life-Tech Intl., Inc.

FDA 510(k) clearance K923071 for DANPLEX DIAGNOSTIC AUDIOMETER, CLIN. DIAG. AUDIOMT, Substantially Equivalent on 1992-09-28. Applicant: Life-Tech Intl., Inc.. Device class: 1.

Clearance details

Applicant: Life-Tech Intl., Inc.
Product code: Code ESD
Device class: Class 1
Regulation: 21 CFR 874.3300
Advisory panel: Ear, Nose, Throat
Date received: 1992-06-25
Decision date: 1992-09-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Houston, TX, US

Download summary PDF View on FDA.gov ↗

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