FDA 510(k)

Freestyle Lancing Device II, Autolet, Autolet Lite, Unilet Lancets

N.º K: K221613 · 2022-10-03

Fecha de decisión2022-10-03

Código de productoQRL

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

Freestyle Lancing Device II, Autolet, Autolet Lite, Unilet Lancets is the device name listed in this FDA 510(k) record. The listed applicant is Owen Mumford, Ltd.. It received FDA 510(k) clearance on 2022-10-03 under 510(k) number K221613. The device is classified under product code QRL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Freestyle Lancing Device II, Autolet, Autolet Lite, Unilet Lancets?

Freestyle Lancing Device II, Autolet, Autolet Lite, Unilet Lancets is a medical device that received FDA 510(k) clearance on 2022-10-03. The listed applicant is Owen Mumford, Ltd.. The 510(k) number is K221613.

When did Freestyle Lancing Device II, Autolet, Autolet Lite, Unilet Lancets receive FDA 510(k) clearance?

Freestyle Lancing Device II, Autolet, Autolet Lite, Unilet Lancets received FDA 510(k) clearance on 2022-10-03, under 510(k) number K221613.

Who is the listed applicant for Freestyle Lancing Device II, Autolet, Autolet Lite, Unilet Lancets?

The FDA 510(k) record lists Owen Mumford, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Freestyle Lancing Device II, Autolet, Autolet Lite, Unilet Lancets?

The FDA product code for Freestyle Lancing Device II, Autolet, Autolet Lite, Unilet Lancets is QRL.

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Otros registros que enlistan a Owen Mumford, Ltd. como solicitante

K223854Unistik® ShieldLock, Unistik VacuFlip K231124Unistik® 3 Single-Use Safety Lancets:- Extra (21G), Normal (23G), Comfort (28G), Gentle (30G)K222168Unistik TinyTouch Steril Single-Use Heel Incisión Seguridad Lancetas - Prematuro y Pleno-Término, Unistik Heelstik Steril Single-Use Heel Incisión Seguridad Lancetas - MicroPrematuro, Prematuro, Pleno-Término y Niño K222303Unistik® Pro K222111Unistik Touch Single-Use Safety Lancets - 16G, 21G, 23G, 28G and 30G K221126Unistik® 3, sterile single-use safety lancets; Unistik® 3 Value, sterile single-use safety lancets; Abbott SF sterile single-use safety lancets

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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.

Fuente oficial

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