FDA 510(k)

RG 3ml Medication Cartridge

Номер K: K201634 · 2021-03-26

ЗаявительChengdu Shifeng Medical Technology Co., Ltd.

Дата решения2021-03-26

Код продуктаMRZ

Консультативный комитетHO

РешениеSubstantially Equivalent

Описание устройства

RG 3ml Medication Cartridge is the device name listed in this FDA 510(k) record. The listed applicant is Chengdu Shifeng Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-03-26 under 510(k) number K201634. The device is classified under product code MRZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the RG 3ml Medication Cartridge?

RG 3ml Medication Cartridge is a medical device that received FDA 510(k) clearance on 2021-03-26. The listed applicant is Chengdu Shifeng Medical Technology Co., Ltd.. The 510(k) number is K201634.

When did RG 3ml Medication Cartridge receive FDA 510(k) clearance?

RG 3ml Medication Cartridge received FDA 510(k) clearance on 2021-03-26, under 510(k) number K201634.

Who is the listed applicant for RG 3ml Medication Cartridge?

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

What is the FDA product code for RG 3ml Medication Cartridge?

The FDA product code for RG 3ml Medication Cartridge is MRZ.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

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Связанные устройства (Код: MRZ)

K230718UTC 3mL Medication CartridgeGilero, LLC K220695Elite Biomedical Solutions Dose Request CordElite Biomedical Solutions K193654BlueStar RxWelldoc, Inc.K191910SpaceStation MRIB. Braun Melsugen AG K190013WellDoc BlueStarWelldoc, Inc.K173531Lockbox for Perfusor Space PCA Infusion PumpB.Braun Medical, Inc.

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