GENESYS AND THE ROI— 510(k) K910002

Name: FDA 510(k) clearance K910002
Creator: U.S. Food and Drug Administration
Published: 1991-07-22

Substantially Equivalent

The Complete Systems Corp. Genesys

FDA 510(k) clearance K910002 for GENESYS AND THE ROI, Substantially Equivalent on 1991-07-22. Applicant: The Complete Systems Corp. Genesys. Device class: 2.

Clearance details

Applicant: The Complete Systems Corp. Genesys
Product code: Code JAI
Device class: Class 2
Regulation: 21 CFR 892.5770
Advisory panel: Radiology
Date received: 1991-01-02
Decision date: 1991-07-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Maitland, FL, US

Download summary PDF View on FDA.gov ↗

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