FDA 510(k)

Disposable Insulin Syringe

N.º K: K162180 · 2016-12-29

SolicitanteBerpu Medical Technology Co., Ltd.

Fecha de decisión2016-12-29

Código de productoFMF

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

Disposable Insulin Syringe is the device name listed in this FDA 510(k) record. The listed applicant is Berpu Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2016-12-29 under 510(k) number K162180. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Disposable Insulin Syringe?

Disposable Insulin Syringe is a medical device that received FDA 510(k) clearance on 2016-12-29. The listed applicant is Berpu Medical Technology Co., Ltd.. The 510(k) number is K162180.

When did Disposable Insulin Syringe receive FDA 510(k) clearance?

Disposable Insulin Syringe received FDA 510(k) clearance on 2016-12-29, under 510(k) number K162180.

Who is the listed applicant for Disposable Insulin Syringe?

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

What is the FDA product code for Disposable Insulin Syringe?

The FDA product code for Disposable Insulin Syringe is FMF.

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Otros registros que enlistan a Berpu Medical Technology Co., Ltd. como solicitante

K232165Sterile Safety Hypodermic Needles for Single Use; Sterile Hypodermic Needles for Single Use- Disposable Needles; Sterile Hypodermic Needles for Single Use- Self-sealing Hypodermic Needles K221045Insulin Syringes without needle K220061Safety Insulin Syringes K213158Syringe with permanently attached needle K213811Sterile Hypodermic Syringes for Single Use K212514Safety Pen Needle for Single Use, Insulin Pen Needles

Ver todos los 9 dispositivos →

Dispositivos relacionados (Código: FMF)

K262581GraftGun Universal Graft Delivery System (GDS®)SurGenTec, LLC K252184SOL-M Luer Lock Syringe with Exchangeable Needle TraySol-Millennium Medical, Inc.K253747Disposable Pen Injector (KXYC-03C02, KXYC-03A03)Jiangsu Enjosim Medical Technology Co., Ltd.K260208Ultra-Fine™ SAFETY Insulin Syringeembecta Medical II, LLC K253110Sol-Glide Safety Needle; Sol-Glide Safety Needle with SyringeSol-Millennium Medical, Inc.K260514Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low Dead Space Syringe with Safety NeedleCMT Health PTE., Ltd.

Fuente oficial

Ver en la base de datos de la FDA →

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