FDA 510(k)

リアンファセーフティランセット（五モデル：NPA、PA、PA2、TPA、およびAPA）

K番号: K222376 · 2022-10-03

申請者Shandong Lianfa Medical Plastic Products Co. , Ltd.

決定日2022-10-03

製品コードFMK

諮問委員会SU （以下のテキストは翻訳されていません。） Policy: medical-regulatory-v1

決定大幅同等

医療機器の概要

Lianfa Safety Lancet (Five Models: NPA, PA, PA2, TPA, and APA) is the device name listed in this FDA 510(k) record. The listed applicant is Shandong Lianfa Medical Plastic Products Co. , Ltd.. It received FDA 510(k) clearance on 2022-10-03 under 510(k) number K222376. The device is classified under product code FMK. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Lianfa Safety Lancet (Five Models: NPA, PA, PA2, TPA, and APA)?

Lianfa Safety Lancet (Five Models: NPA, PA, PA2, TPA, and APA) is a medical device that received FDA 510(k) clearance on 2022-10-03. The listed applicant is Shandong Lianfa Medical Plastic Products Co. , Ltd.. The 510(k) number is K222376.

When did Lianfa Safety Lancet (Five Models: NPA, PA, PA2, TPA, and APA) receive FDA 510(k) clearance?

Lianfa Safety Lancet (Five Models: NPA, PA, PA2, TPA, and APA) received FDA 510(k) clearance on 2022-10-03, under 510(k) number K222376.

Who is the listed applicant for Lianfa Safety Lancet (Five Models: NPA, PA, PA2, TPA, and APA)?

The FDA 510(k) record lists Shandong Lianfa Medical Plastic Products Co. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Lianfa Safety Lancet (Five Models: NPA, PA, PA2, TPA, and APA)?

The FDA product code for Lianfa Safety Lancet (Five Models: NPA, PA, PA2, TPA, and APA) is FMK.

申請者としてShandong Lianfa Medical Plastic Products Co. , Ltd.を記載するその他の記録

K222472レーザンシステム、一次性使用の無菌レーザン、レーザン装置

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