FDA 510(k)

Insulin Syringes without needle

Número K: K221045 · 2022-11-03

RequerenteBerpu Medical Technology Co., Ltd.

Data da decisão2022-11-03

Código do produtoFMF

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Insulin Syringes without needle 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 2022-11-03 under 510(k) number K221045. 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 Insulin Syringes without needle?

Insulin Syringes without needle is a medical device that received FDA 510(k) clearance on 2022-11-03. The listed applicant is Berpu Medical Technology Co., Ltd.. The 510(k) number is K221045.

When did Insulin Syringes without needle receive FDA 510(k) clearance?

Insulin Syringes without needle received FDA 510(k) clearance on 2022-11-03, under 510(k) number K221045.

Who is the listed applicant for Insulin Syringes without needle?

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 Insulin Syringes without needle?

The FDA product code for Insulin Syringes without needle 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 K220061Safety Insulin Syringes K213158Syringe with permanently attached needle K213811Sterile Hypodermic Syringes for Single Use K212514Safety Pen Needle for Single Use, Insulin Pen Needles K181447Safety insulin needle for single use

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Fonte oficial

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