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FDA 510(k)

Le'Pen

K-Number: K181597 · 2019-04-01

ApplicantKmihh, Ltd.
Decision Date2019-04-01
Product CodeEBZ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Le'Pen is a medical device manufactured by Kmihh, Ltd.. It received FDA 510(k) clearance on 2019-04-01 under approval number K181597. The device is classified under product code EBZ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Le'Pen?

Le'Pen is a medical device that received FDA 510(k) clearance on 2019-04-01. It is manufactured by Kmihh, Ltd.. The 510(k) number is K181597.

When was Le'Pen approved by the FDA?

Le'Pen received FDA 510(k) clearance on 2019-04-01, under approval number K181597.

What company makes Le'Pen?

Le'Pen is manufactured by Kmihh, Ltd..

What is the FDA product code for Le'Pen?

The FDA product code for Le'Pen is EBZ.

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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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