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FDA 510(k)

KBL 7000 alpha hybridSun, KBL 7900 alpha hybridSun, KBL 8000 alpha hybridSun

K-Number: K191881 · 2019-10-28

ApplicantKbl GmbH
Decision Date2019-10-28
Product CodeLEJ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

KBL 7000 alpha hybridSun, KBL 7900 alpha hybridSun, KBL 8000 alpha hybridSun is a medical device manufactured by Kbl GmbH. It received FDA 510(k) clearance on 2019-10-28 under approval number K191881. 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 KBL 7000 alpha hybridSun, KBL 7900 alpha hybridSun, KBL 8000 alpha hybridSun?

KBL 7000 alpha hybridSun, KBL 7900 alpha hybridSun, KBL 8000 alpha hybridSun is a medical device that received FDA 510(k) clearance on 2019-10-28. It is manufactured by Kbl GmbH. The 510(k) number is K191881.

When was KBL 7000 alpha hybridSun, KBL 7900 alpha hybridSun, KBL 8000 alpha hybridSun approved by the FDA?

KBL 7000 alpha hybridSun, KBL 7900 alpha hybridSun, KBL 8000 alpha hybridSun received FDA 510(k) clearance on 2019-10-28, under approval number K191881.

What company makes KBL 7000 alpha hybridSun, KBL 7900 alpha hybridSun, KBL 8000 alpha hybridSun?

KBL 7000 alpha hybridSun, KBL 7900 alpha hybridSun, KBL 8000 alpha hybridSun is manufactured by Kbl GmbH.

What is the FDA product code for KBL 7000 alpha hybridSun, KBL 7900 alpha hybridSun, KBL 8000 alpha hybridSun?

The FDA product code for KBL 7000 alpha hybridSun, KBL 7900 alpha hybridSun, KBL 8000 alpha hybridSun 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.

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