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FDA 510(k)

RealNow

K-Number: K213891 · 2023-02-24

ApplicantYiwei Medical Technology Co., Ltd.
Decision Date2023-02-24
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

RealNow is a medical device manufactured by Yiwei Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-02-24 under approval number K213891. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RealNow?

RealNow is a medical device that received FDA 510(k) clearance on 2023-02-24. It is manufactured by Yiwei Medical Technology Co., Ltd.. The 510(k) number is K213891.

When was RealNow approved by the FDA?

RealNow received FDA 510(k) clearance on 2023-02-24, under approval number K213891.

What company makes RealNow?

RealNow is manufactured by Yiwei Medical Technology Co., Ltd..

What is the FDA product code for RealNow?

The FDA product code for RealNow is LLZ.

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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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