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FDA 510(k)

Ergoline Sunrise 7200 Hybrid Technology

K-Number: K183539 · 2019-04-08

ApplicantJk-Holding GmbH
Decision Date2019-04-08
Product CodeLEJ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Ergoline Sunrise 7200 Hybrid Technology is a medical device manufactured by Jk-Holding GmbH. It received FDA 510(k) clearance on 2019-04-08 under approval number K183539. 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 Sunrise 7200 Hybrid Technology?

Ergoline Sunrise 7200 Hybrid Technology is a medical device that received FDA 510(k) clearance on 2019-04-08. It is manufactured by Jk-Holding GmbH. The 510(k) number is K183539.

When was Ergoline Sunrise 7200 Hybrid Technology approved by the FDA?

Ergoline Sunrise 7200 Hybrid Technology received FDA 510(k) clearance on 2019-04-08, under approval number K183539.

What company makes Ergoline Sunrise 7200 Hybrid Technology?

Ergoline Sunrise 7200 Hybrid Technology is manufactured by Jk-Holding GmbH.

What is the FDA product code for Ergoline Sunrise 7200 Hybrid Technology?

The FDA product code for Ergoline Sunrise 7200 Hybrid Technology is LEJ.

Related Clinical Trials

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Other Devices by Jk-Holding GmbH

K173565Sunrise 6200, Sunrise 7200 K190173Ergoline Inspiration 550 Hybrid Technology / Sound, Ergoline Inspiration 550 Hybrid Technology / AC / Sound, Ergoline Planet Fitness 42/4 Hybrid Light Technology / Sound K220500Ergoline Vitality Total Light 3, Planet Fitness 50/4 TLT by Ergoline, Planet Fitness 42/3 TLT by Ergoline, Ergoline Vitality Hybrid Light 3, Ergoline Vitality Hybrid Light, Planet Fitness 50/4 HLT by Ergoline, Planet Fitness 46/3 HLT by Ergoline, Ergoline Vitality Pure Light 3, Ergoline Vitality Pure Light, Planet Fitness 50/4 PLT III by Ergoline, Planet Fitness 50/4 PLT by Ergoline, Planet Fitness 46/3 PLT by Ergoline, Planet Fitness 42/3 PLT by Ergoline

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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.

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