Prelude
K-Number: K180308 · 2018-03-27
ApplicantMedcom GmbH
Decision Date2018-03-27
Product CodeMUJ
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Prelude is a medical device manufactured by Medcom GmbH. It received FDA 510(k) clearance on 2018-03-27 under approval number K180308. The device is classified under product code MUJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Prelude?
Prelude is a medical device that received FDA 510(k) clearance on 2018-03-27. It is manufactured by Medcom GmbH. The 510(k) number is K180308.
When was Prelude approved by the FDA?
Prelude received FDA 510(k) clearance on 2018-03-27, under approval number K180308.
What company makes Prelude?
Prelude is manufactured by Medcom GmbH.
What is the FDA product code for Prelude?
The FDA product code for Prelude is MUJ.
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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.