GX-ELEVATOR— 510(k) K894188

Substantially Equivalent

Gendex Corp.

FDA 510(k) clearance K894188 for GX-ELEVATOR, Substantially Equivalent on 1989-10-03. Applicant: Gendex Corp.. Device class: 2.

Clearance details

Applicant: Gendex Corp.
Product code: Code IZZ
Device class: Class 2
Regulation: 21 CFR 892.1980
Advisory panel: Radiology
Date received: 1989-06-16
Decision date: 1989-10-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Franklin Park, 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.