MCI OPTONIX CASSETTE OKAMOTO CASSETE— 510(k) K945039

Name: FDA 510(k) clearance K945039
Creator: U.S. Food and Drug Administration
Published: 1994-11-22

Substantially Equivalent

Mci Optonix, Inc.

FDA 510(k) clearance K945039 for MCI OPTONIX CASSETTE OKAMOTO CASSETE, Substantially Equivalent on 1994-11-22. Applicant: Mci Optonix, Inc.. Device class: 2.

Clearance details

Applicant: Mci Optonix, Inc.
Product code: Code IXA
Device class: Class 2
Regulation: 21 CFR 892.1850
Advisory panel: Radiology
Date received: 1994-10-14
Decision date: 1994-11-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cedar Knolls, NJ, US

Download summary PDF View on FDA.gov ↗

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