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FDA 510(k)

RAREX GREEN FAST

K-Number: K941023 · 1994-03-30

ApplicantMci Optonix, Inc.
Decision Date1994-03-30
Product CodeEAM
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

RAREX GREEN FAST is the device name listed in this FDA 510(k) record. The listed applicant is Mci Optonix, Inc.. It received FDA 510(k) clearance on 1994-03-30 under 510(k) number K941023. The device is classified under product code EAM. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RAREX GREEN FAST?

RAREX GREEN FAST is a medical device that received FDA 510(k) clearance on 1994-03-30. The listed applicant is Mci Optonix, Inc.. The 510(k) number is K941023.

When did RAREX GREEN FAST receive FDA 510(k) clearance?

RAREX GREEN FAST received FDA 510(k) clearance on 1994-03-30, under 510(k) number K941023.

Who is the listed applicant for RAREX GREEN FAST?

The FDA 510(k) record lists Mci Optonix, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RAREX GREEN FAST?

The FDA product code for RAREX GREEN FAST is EAM.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Mci Optonix, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K953444MCI OPTONIX ECONOMY CASSETTEK945039MCI OPTONIX CASSETTE OKAMOTO CASSETEK902039RAREX & OPTEX X-RAY SCREENS

Related Devices (Code: EAM)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K974423ULTRA-VISION MAMMOGRAPHY DETAIL, ULTRA-VISION MAMMOGRAPHY FAST DETAILSterling Diagnostic Imaging, Inc.K963913MD100 & MM150Konica Medical Corp.K954161JPI INTENSIFYING SCREENJpi Healthcare Co, Ltd.K943822FUJI UM MAMMO SERIES INTENSIFY SCREENS:Fujifilm Medical System U.S.A., Inc.K943823FUJI FG SERIES INTENSIFYING SCREENS: FG-3-4-8-12Fujifilm Medical System U.S.A., Inc.K943821KYOKKO SPEC-SERIES INTENSIFY SCREENS-SPEC,SUPER SPECFujifilm Medical System U.S.A., Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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