FDA 510(k)

Medifun Lancing Device, Model No. LD-E1

Número K: K231797 · 2023-11-22

Data da decisão2023-11-22

Código do produtoQRL

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Medifun Lancing Device, Model No. LD-E1 is the device name listed in this FDA 510(k) record. The listed applicant is Medifun Corporation. It received FDA 510(k) clearance on 2023-11-22 under 510(k) number K231797. The device is classified under product code QRL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Medifun Lancing Device, Model No. LD-E1?

Medifun Lancing Device, Model No. LD-E1 is a medical device that received FDA 510(k) clearance on 2023-11-22. The listed applicant is Medifun Corporation. The 510(k) number is K231797.

When did Medifun Lancing Device, Model No. LD-E1 receive FDA 510(k) clearance?

Medifun Lancing Device, Model No. LD-E1 received FDA 510(k) clearance on 2023-11-22, under 510(k) number K231797.

Who is the listed applicant for Medifun Lancing Device, Model No. LD-E1?

The FDA 510(k) record lists Medifun Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Medifun Lancing Device, Model No. LD-E1?

The FDA product code for Medifun Lancing Device, Model No. LD-E1 is QRL.

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Outros registros que listam Medifun Corporation como candidato(a)

K241750Medifun Safety Lancet ( MSL1 series)

Dispositivos Relacionados (Código: QRL)

K262135Lancing deviceTianjin Huahong Technology Co., Ltd.K262211LancetTianjin Huahong Technology Co., Ltd.K260122Lancing Device (PressGo, LDE3, LDE3AST, LDE5, EasyStep)SteriLance Medical (Suzhou), Inc.K253706Lancing device (HH-XV-T)Tianjin Huahong Technology Co., Ltd.K250813MICROLET®NEXT 2 Lancing DeviceAscensia Diabetes Care U.S., Inc.K243306Lancet (IA, IB, IC, ID, IE, IK, IL, IM, IIA, IIB, III, V, VI, VII, VIII, IX); Lancing device (HH-X-T, HH-XV-T, HH-XVI-T, HH-XVII-T, HH-XVIII-T, HH-XIX, HH-XXI-T, HH-XXII-T, HH-XXIII-T, HH-XXIV-T, HH-XXV-T, HH-XXVI-T, HH-XXVIII-T, HH-XXIX-T, HH-XXX-T, HH-XIII-T, HH-XXVII-T)Tianjin Huahong Technology Co., Ltd.

Fonte oficial

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