FDA 510(k)

Localisateur Apex (AL-Pex), Localisateur Apex (AL-Pex+)

Numéro K : K232717 · 2023-12-22

DemandeurChangzhou Haili Medical Co., Ltd.

Date de décision2023-12-22

Code produitLQY

DécisionSubstantially Equivalent

Résumé du dispositif

Apex Locator (AL-Pex), Apex Locator (AL-Pex+) is the device name listed in this FDA 510(k) record. The listed applicant is Changzhou Haili Medical Co., Ltd.. It received FDA 510(k) clearance on 2023-12-22 under 510(k) number K232717. The device is classified under product code LQY. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Apex Locator (AL-Pex), Apex Locator (AL-Pex+)?

Apex Locator (AL-Pex), Apex Locator (AL-Pex+) is a medical device that received FDA 510(k) clearance on 2023-12-22. The listed applicant is Changzhou Haili Medical Co., Ltd.. The 510(k) number is K232717.

When did Apex Locator (AL-Pex), Apex Locator (AL-Pex+) receive FDA 510(k) clearance?

Apex Locator (AL-Pex), Apex Locator (AL-Pex+) received FDA 510(k) clearance on 2023-12-22, under 510(k) number K232717.

Who is the listed applicant for Apex Locator (AL-Pex), Apex Locator (AL-Pex+)?

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

What is the FDA product code for Apex Locator (AL-Pex), Apex Locator (AL-Pex+)?

The FDA product code for Apex Locator (AL-Pex), Apex Locator (AL-Pex+) is LQY.

Essais cliniques associés

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Dispositifs connexes (Code : LQY)

K252224Localisateur Apex (FindPex)Changzhou Sifary Medical Technology Co., Ltd.K242383Localisateur ApexShenzhen Rogin Medical Co., Ltd.K242765Electronic Apex Locator (Alpha Apex I)SHENZHEN SUPERLINE TECHNOLOGY CO., LTD.K231990Localisateur ApexCefla S.C.K212178Root Apex LocatorFoshan Coxo Medical Instrument Co., Ltd.K210789EQ-PEXMeta Systems Co., Ltd.

Source officielle

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