FDA 510(k)

Safety butterfly type blood collection needle, Butterfly type blood collection needle, Pen type blood collection needle, Safety pen

Numéro K : K213146 · 2023-10-27

DemandeurJiangsu Rongye Technology Co., Ltd.

Date de décision2023-10-27

Code produitJKA

Comité consultatifCH

DécisionSubstantially Equivalent

Résumé du dispositif

Safety butterfly type blood collection needle, Butterfly type blood collection needle, Pen type blood collection needle, Safety pen is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Rongye Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-10-27 under 510(k) number K213146. The device is classified under product code JKA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Safety butterfly type blood collection needle, Butterfly type blood collection needle, Pen type blood collection needle, Safety pen?

Safety butterfly type blood collection needle, Butterfly type blood collection needle, Pen type blood collection needle, Safety pen is a medical device that received FDA 510(k) clearance on 2023-10-27. The listed applicant is Jiangsu Rongye Technology Co., Ltd.. The 510(k) number is K213146.

When did Safety butterfly type blood collection needle, Butterfly type blood collection needle, Pen type blood collection needle, Safety pen receive FDA 510(k) clearance?

Safety butterfly type blood collection needle, Butterfly type blood collection needle, Pen type blood collection needle, Safety pen received FDA 510(k) clearance on 2023-10-27, under 510(k) number K213146.

Who is the listed applicant for Safety butterfly type blood collection needle, Butterfly type blood collection needle, Pen type blood collection needle, Safety pen?

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

What is the FDA product code for Safety butterfly type blood collection needle, Butterfly type blood collection needle, Pen type blood collection needle, Safety pen?

The FDA product code for Safety butterfly type blood collection needle, Butterfly type blood collection needle, Pen type blood collection needle, Safety pen is JKA.

Essais cliniques associés

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Dispositifs connexes (Code : JKA)

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Source officielle

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