FDA 510(k)

AMSafe(R) Pre-Filled Normal Saline Flush Syringe

N.º K: K183473 · 2019-07-12

Fecha de decisión2019-07-12

Código de productoNGT

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

AMSafe(R) Pre-Filled Normal Saline Flush Syringe is the device name listed in this FDA 510(k) record. The listed applicant is Amsino International, Inc.. It received FDA 510(k) clearance on 2019-07-12 under 510(k) number K183473. The device is classified under product code NGT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the AMSafe(R) Pre-Filled Normal Saline Flush Syringe?

AMSafe(R) Pre-Filled Normal Saline Flush Syringe is a medical device that received FDA 510(k) clearance on 2019-07-12. The listed applicant is Amsino International, Inc.. The 510(k) number is K183473.

When did AMSafe(R) Pre-Filled Normal Saline Flush Syringe receive FDA 510(k) clearance?

AMSafe(R) Pre-Filled Normal Saline Flush Syringe received FDA 510(k) clearance on 2019-07-12, under 510(k) number K183473.

Who is the listed applicant for AMSafe(R) Pre-Filled Normal Saline Flush Syringe?

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

What is the FDA product code for AMSafe(R) Pre-Filled Normal Saline Flush Syringe?

The FDA product code for AMSafe(R) Pre-Filled Normal Saline Flush Syringe is NGT.

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Otros registros que enlistan a Amsino International, Inc. como solicitante

K252543AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04)K220230AMSure Enteral Feeding Pump K220267AMSafe NeuFlo Needleless Connector K213522AMSafe Pre-Filled Normal Saline Flush Syringe K200051PUGGLE Enteral Feeding Pump and Feeding Set K181445Catéter Intermítente Hidrofílico AMSure

Ver todos los 11 dispositivos →

Dispositivos relacionados (Código: NGT)

K250884Inyección de Cloruro de Sodio al 0.9 %, USP, Jeringa BD PosiFlush™ SPBecton, Dickinson and Company K233623Praxiject™ SP 0.9% NaClMedxl, Inc.K231724Flush Syringe (Prefilled 0.9% normal saline solution)Spm Medicare Pvt. , Ltd.K231363Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, PFS-1010)Hantech Medical Device Co., Ltd.K230756TK Pre-Filled Normal Saline Flush SyringeAnhui Tiankang Medical Technology Co., Ltd.K223584Pre-Filled Normal Saline Flush SyringeAnhui Tianyang Pharmaceutical Co., Ltd.

Fuente oficial

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