FDA 510(k)

Irrigation Tubing with CO2 or Air

Номер K: K193250 · 2020-04-06

ЗаявительKeymed (Medical and Industrial Equipment) , Ltd.

Дата решения2020-04-06

Код продуктаOCX

Консультативный комитетGU

РешениеSubstantially Equivalent

Описание устройства

Irrigation Tubing with CO2 or Air is the device name listed in this FDA 510(k) record. The listed applicant is Keymed (Medical and Industrial Equipment) , Ltd.. It received FDA 510(k) clearance on 2020-04-06 under 510(k) number K193250. The device is classified under product code OCX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Irrigation Tubing with CO2 or Air?

Irrigation Tubing with CO2 or Air is a medical device that received FDA 510(k) clearance on 2020-04-06. The listed applicant is Keymed (Medical and Industrial Equipment) , Ltd.. The 510(k) number is K193250.

When did Irrigation Tubing with CO2 or Air receive FDA 510(k) clearance?

Irrigation Tubing with CO2 or Air received FDA 510(k) clearance on 2020-04-06, under 510(k) number K193250.

Who is the listed applicant for Irrigation Tubing with CO2 or Air?

The FDA 510(k) record lists Keymed (Medical and Industrial Equipment) , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Irrigation Tubing with CO2 or Air?

The FDA product code for Irrigation Tubing with CO2 or Air is OCX.

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: OCX)

K251986AUXILIARY WATER TUBE MAJ-855Olympus Medical Systems Corporation K251997Single-Use Biopsy Valve (MAJ-1555)Olympus Medical Systems Corporation K242586ArgoCap (200.52)Ovesco Endoscopy AG K241704Endoscopic Water PumpHangzhou AGS MedTech Co., Ltd.K242357Water Container (MAJ-901); Water Container (MAJ-902)Olympus Medical Systems Corporation K241874Aspiration Catheter (2189)Hobbs Medical, Inc.

Официальный источник

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