MCI - CMF System
K-Number: K182758 · 2019-12-05
ApplicantMci Medical Concept Innovation, Inc.
Decision Date2019-12-05
Product CodeJEY
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
MCI - CMF System is a medical device manufactured by Mci Medical Concept Innovation, Inc.. It received FDA 510(k) clearance on 2019-12-05 under approval number K182758. The device is classified under product code JEY. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the MCI - CMF System?
MCI - CMF System is a medical device that received FDA 510(k) clearance on 2019-12-05. It is manufactured by Mci Medical Concept Innovation, Inc.. The 510(k) number is K182758.
When was MCI - CMF System approved by the FDA?
MCI - CMF System received FDA 510(k) clearance on 2019-12-05, under approval number K182758.
What company makes MCI - CMF System?
MCI - CMF System is manufactured by Mci Medical Concept Innovation, Inc..
What is the FDA product code for MCI - CMF System?
The FDA product code for MCI - CMF System is JEY.
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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.