FDA 510(k)

Kava and Kava with Herbst

K-Number: K182661 · 2019-02-13

Decision Date2019-02-13

Product CodeLRK

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

Kava and Kava with Herbst is the device name listed in this FDA 510(k) record. The listed applicant is Sketchpad Innovations, LLC. It received FDA 510(k) clearance on 2019-02-13 under 510(k) number K182661. The device is classified under product code LRK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Kava and Kava with Herbst?

Kava and Kava with Herbst is a medical device that received FDA 510(k) clearance on 2019-02-13. The listed applicant is Sketchpad Innovations, LLC. The 510(k) number is K182661.

When did Kava and Kava with Herbst receive FDA 510(k) clearance?

Kava and Kava with Herbst received FDA 510(k) clearance on 2019-02-13, under 510(k) number K182661.

Who is the listed applicant for Kava and Kava with Herbst?

The FDA 510(k) record lists Sketchpad Innovations, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Kava and Kava with Herbst?

The FDA product code for Kava and Kava with Herbst is LRK.

Related Devices (Code: LRK)

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.