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FDA 510(k)

Type I, Type II, Type III, Type IV

K-Number: K172331 · 2018-03-02

ApplicantLepu Medical Technology (Beijing) Co., Ltd.
Decision Date2018-03-02
Product CodeDYB
Advisory CommitteeCV
DecisionUnknown

Device Summary

Type I, Type II, Type III, Type IV is the device name listed in this FDA 510(k) record. The listed applicant is Lepu Medical Technology (Beijing) Co., Ltd.. It received FDA 510(k) clearance on 2018-03-02 under 510(k) number K172331. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the Type I, Type II, Type III, Type IV?

Type I, Type II, Type III, Type IV is a medical device that received FDA 510(k) clearance on 2018-03-02. The listed applicant is Lepu Medical Technology (Beijing) Co., Ltd.. The 510(k) number is K172331.

When did Type I, Type II, Type III, Type IV receive FDA 510(k) clearance?

Type I, Type II, Type III, Type IV received FDA 510(k) clearance on 2018-03-02, under 510(k) number K172331.

Who is the listed applicant for Type I, Type II, Type III, Type IV?

The FDA 510(k) record lists Lepu Medical Technology (Beijing) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Type I, Type II, Type III, Type IV?

The FDA product code for Type I, Type II, Type III, Type IV is DYB.

Other records listing Lepu Medical Technology (Beijing) Co., Ltd. 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.

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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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