FDA 510(k)

Disposable Insulin Syringe

Número K: K162180 · 2016-12-29

RequerenteBerpu Medical Technology Co., Ltd.

Data da decisão2016-12-29

Código do produtoFMF

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do 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.

Perguntas frequentes

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

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

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Fonte oficial

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