FDA 510(k)

TK Safety Needle

N.º K: K191644 · 2020-08-06

SolicitanteAnhui Tiankang Medical Technology Co., Ltd.

Fecha de decisión2020-08-06

Código de productoFMI

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

TK Safety Needle 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 2020-08-06 under 510(k) number K191644. 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 TK Safety Needle?

TK Safety Needle is a medical device that received FDA 510(k) clearance on 2020-08-06. The listed applicant is Anhui Tiankang Medical Technology Co., Ltd.. The 510(k) number is K191644.

When did TK Safety Needle receive FDA 510(k) clearance?

TK Safety Needle received FDA 510(k) clearance on 2020-08-06, under 510(k) number K191644.

Who is the listed applicant for TK Safety Needle?

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 Safety Needle?

The FDA product code for TK Safety Needle is FMI.

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Dispositivos relacionados (Código: FMI)

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Fuente oficial

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