FDA 510(k)

TK Pre-Filled Normal Saline Flush Syringe

Número K: K230756 · 2023-08-12

RequerenteAnhui Tiankang Medical Technology Co., Ltd.

Data da decisão2023-08-12

Código do produtoNGT

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

TK Pre-Filled Normal Saline Flush Syringe is the device name listed in this FDA 510(k) record. The listed applicant is Anhui Tiankang Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-08-12 under 510(k) number K230756. The device is classified under product code NGT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the TK Pre-Filled Normal Saline Flush Syringe?

TK Pre-Filled Normal Saline Flush Syringe is a medical device that received FDA 510(k) clearance on 2023-08-12. The listed applicant is Anhui Tiankang Medical Technology Co., Ltd.. The 510(k) number is K230756.

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

TK Pre-Filled Normal Saline Flush Syringe received FDA 510(k) clearance on 2023-08-12, under 510(k) number K230756.

Who is the listed applicant for TK Pre-Filled Normal Saline Flush Syringe?

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

What is the FDA product code for TK Pre-Filled Normal Saline Flush Syringe?

The FDA product code for TK Pre-Filled Normal Saline Flush Syringe is NGT.

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Outros registros que listam Anhui Tiankang Medical Technology Co., Ltd. como candidato(a)

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Dispositivos Relacionados (Código: NGT)

K250884Injeção de Sódio Clorídrico 0,9 %, USP, Siringa 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.K223584Pre-Filled Normal Saline Flush SyringeAnhui Tianyang Pharmaceutical Co., Ltd.K231161Injeção de Sódio Clorídrico 0,9 %, USP BD PosiFlush™ SF Siringa de Desinfecção de SalinaBecton, Dickinson and Company

Fonte oficial

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