FDA 510(k)

Single Use Injector NM600/610

N.º K: K153625 · 2016-02-12

SolicitanteOlympus Medical Systems Corp.

Fecha de decisión2016-02-12

Código de productoFBK

Comité asesorGU

DecisiónSubstantially Equivalent

Resumen del dispositivo

Single Use Injector NM600/610 is the device name listed in this FDA 510(k) record. The listed applicant is Olympus Medical Systems Corp.. It received FDA 510(k) clearance on 2016-02-12 under 510(k) number K153625. The device is classified under product code FBK. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Single Use Injector NM600/610?

Single Use Injector NM600/610 is a medical device that received FDA 510(k) clearance on 2016-02-12. The listed applicant is Olympus Medical Systems Corp.. The 510(k) number is K153625.

When did Single Use Injector NM600/610 receive FDA 510(k) clearance?

Single Use Injector NM600/610 received FDA 510(k) clearance on 2016-02-12, under 510(k) number K153625.

Who is the listed applicant for Single Use Injector NM600/610?

The FDA 510(k) record lists Olympus Medical Systems Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Single Use Injector NM600/610?

The FDA product code for Single Use Injector NM600/610 is FBK.

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Otros registros que enlistan a Olympus Medical Systems Corp. como solicitante

K2620794K Camera Head OLYMPUS CH-S700-08-LB K254056THUNDERBEAT 5 mm, 45 cm, Tipo de Sujeción Actuada en la Frente S (TB-0545FCS); THUNDERBEAT 5 mm, 35 cm, Tipo de Sujeción Actuada en la Frente S (TB-0535FCS); THUNDERBEAT 5 mm, 20 cm, Tipo de Sujeción Actuada en la Frente S (TB-0520FCS)K260580Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR); Clip (HX-610-090, HX-610-135); Long Clip (HX-610-090L, HX-610-135L); Short Clip (HX-610-090S, HX-610-135S); Super Short Clip (HX-610-135XS)K252341EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-Q190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-H190 ); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-1TH190)K251807Single Use Electrosurgical Hemostatic Forceps FD-410LR, FD-411UR, FD-412LR K253646Single Use Distal Cover MAJ-2315 (MAJ-2315)

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Dispositivos relacionados (Código: FBK)

K260262Injection NeedleMirco-Tech (Nanjing) Co., Ltd.K253598InjecSURE Injection SystemCarbon Medical Technologies, Inc.K252021Disposable Endoscopic Injection NeedlesChangzhou New Med Micro-Medtech Co., Ltd.K252247Injector Force Max Single Use Injector (NM-400L); Injector Force Max Single Use Injector (NM-400U); Injector Force Max Single Use Injector (NM-400Y); Injector Force Max Single Use Injector (NM-401L)Olympus Medical Systems Corporation K241595EzVu Visual Vasopressor injector (EV-19)Veol Medical Technologies Pvt , Ltd.K240675Endoscopic Injection NeedlesPromisemed Hangzhou Meditech Co., Ltd.

Fuente oficial

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