Ergoline Prestige 1600 Hybrid Performance
K-Number: K180555 · 2018-10-11
ApplicantJk Holding GmbH
Decision Date2018-10-11
Product CodeLEJ
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Ergoline Prestige 1600 Hybrid Performance is a medical device manufactured by Jk Holding GmbH. It received FDA 510(k) clearance on 2018-10-11 under approval number K180555. The device is classified under product code LEJ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Ergoline Prestige 1600 Hybrid Performance?
Ergoline Prestige 1600 Hybrid Performance is a medical device that received FDA 510(k) clearance on 2018-10-11. It is manufactured by Jk Holding GmbH. The 510(k) number is K180555.
When was Ergoline Prestige 1600 Hybrid Performance approved by the FDA?
Ergoline Prestige 1600 Hybrid Performance received FDA 510(k) clearance on 2018-10-11, under approval number K180555.
What company makes Ergoline Prestige 1600 Hybrid Performance?
Ergoline Prestige 1600 Hybrid Performance is manufactured by Jk Holding GmbH.
What is the FDA product code for Ergoline Prestige 1600 Hybrid Performance?
The FDA product code for Ergoline Prestige 1600 Hybrid Performance is LEJ.
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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.