JANUS ATAC ENG ANALYSIS SYSTEM— 510(k) K904385

Name: FDA 510(k) clearance K904385
Creator: U.S. Food and Drug Administration
Published: 1992-06-10

Substantially Equivalent

Life-Tech Intl., Inc.

FDA 510(k) clearance K904385 for JANUS ATAC ENG ANALYSIS SYSTEM, Substantially Equivalent on 1992-06-10. Applicant: Life-Tech Intl., Inc.. Device class: 2.

Clearance details

Applicant: Life-Tech Intl., Inc.
Product code: Code GWN
Device class: Class 2
Regulation: 21 CFR 882.1460
Advisory panel: Neurology
Date received: 1990-09-24
Decision date: 1992-06-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Houston, TX, US

Download summary PDF View on FDA.gov ↗

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