RAREX GREEN FAST— 510(k) K941023

Substantially Equivalent

Mci Optonix, Inc.

FDA 510(k) clearance K941023 for RAREX GREEN FAST, Substantially Equivalent on 1994-03-30. Applicant: Mci Optonix, Inc.. Device class: 1.

Clearance details

Applicant: Mci Optonix, Inc.
Product code: Code EAM
Device class: Class 1
Regulation: 21 CFR 892.1960
Advisory panel: Radiology
Date received: 1994-03-03
Decision date: 1994-03-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cedar Knolls, NJ, 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.