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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 the device name listed in this FDA 510(k) record. The listed applicant is Kbl GmbH. It received FDA 510(k) clearance on 2019-10-28 under 510(k) 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. The listed applicant is Kbl GmbH. The 510(k) number is K191881.

When did KBL 7000 alpha hybridSun, KBL 7900 alpha hybridSun, KBL 8000 alpha hybridSun receive FDA 510(k) clearance?

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

Who is the listed applicant for KBL 7000 alpha hybridSun, KBL 7900 alpha hybridSun, KBL 8000 alpha hybridSun?

The FDA 510(k) record lists Kbl GmbH as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Kbl GmbH as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K151962KBL Sunlamp Products (= Device Bundling name)

Related Devices (Code: LEJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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