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FDA 510(k)

CareSens Pen Needle, Softip Pen Needle

N.º K: K160575 · 2016-09-07

SolicitanteYidobio, Inc.
Fecha de decisión2016-09-07
Código de productoFMI
Comité asesorHO
DecisiónSubstantially Equivalent

Resumen del dispositivo

CareSens Pen Needle, Softip Pen Needle is the device name listed in this FDA 510(k) record. The listed applicant is Yidobio, Inc.. It received FDA 510(k) clearance on 2016-09-07 under 510(k) number K160575. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the CareSens Pen Needle, Softip Pen Needle?

CareSens Pen Needle, Softip Pen Needle is a medical device that received FDA 510(k) clearance on 2016-09-07. The listed applicant is Yidobio, Inc.. The 510(k) number is K160575.

When did CareSens Pen Needle, Softip Pen Needle receive FDA 510(k) clearance?

CareSens Pen Needle, Softip Pen Needle received FDA 510(k) clearance on 2016-09-07, under 510(k) number K160575.

Who is the listed applicant for CareSens Pen Needle, Softip Pen Needle?

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

What is the FDA product code for CareSens Pen Needle, Softip Pen Needle?

The FDA product code for CareSens Pen Needle, Softip Pen Needle is FMI.

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Dispositivos relacionados (Código: FMI)

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

K261266MOWANA™ Auto DuoPENTAMASTER MEDIQ SDN BHDK261719Promisemed X-Safety Pen NeedlePromisemed Hangzhou Meditech Co., Ltd.K262427Pen Needle (Ordinary Type I, Safety Type IIA, Safety Type IIB, Safety Type IIIA, Safety Type IIIB, Safety Type IV, Safety Type V, Ordinary Type VIA, Ordinary Type VIB, Ordinary Type VIC, Safety Type VII, Ordinary Type IB, Safety type VIII, Safety Type IX, Safety Type X, Ordinary Type XI, Safety Type XII)Hh Global Technology, Inc.K260933Safety Sterile Hypodermic Needles (NR-S1816R, NR-S1916R, NR-S1925R, NR-S1938R, NR-S2016R, NR-S2025R, NR-S2038R, NR-S2051R, NR-S2116R, NR-S2125R, NR-S2138R, NR-S2151R, NR-S2216R, NR-S2225R, NR-S2238R, NR-S2251R, NR-S2316R, NR-S2325R, NR-S2338R, NR-S2351R, NR-S2516R, NR-S2525R, NR-S2538R, NR-S2551R, NR-S2516T, NR-S2525T, NR-S2538T, NR-S2551T)Hangzhou Qiantang Longyue Biotechnology Co., Ltd.K261829Profoject™ Dual-Safety Pen NeedlesCMT Health PTE., Ltd.K260739Profoject™ Pen Needles (Model A; Model B)CMT Health PTE., Ltd.

Fuente oficial

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