FDA 510(k)

Sheathes Ultrasound Probe Covers

Номер K: K153212 · 2016-03-04

Дата решения2016-03-04

Код продуктаITX

Консультативный комитетRA

РешениеSubstantially Equivalent

Описание устройства

Sheathes Ultrasound Probe Covers is the device name listed in this FDA 510(k) record. The listed applicant is Sheathing Technologies, Inc.. It received FDA 510(k) clearance on 2016-03-04 under 510(k) number K153212. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Sheathes Ultrasound Probe Covers?

Sheathes Ultrasound Probe Covers is a medical device that received FDA 510(k) clearance on 2016-03-04. The listed applicant is Sheathing Technologies, Inc.. The 510(k) number is K153212.

When did Sheathes Ultrasound Probe Covers receive FDA 510(k) clearance?

Sheathes Ultrasound Probe Covers received FDA 510(k) clearance on 2016-03-04, under 510(k) number K153212.

Who is the listed applicant for Sheathes Ultrasound Probe Covers?

The FDA 510(k) record lists Sheathing Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sheathes Ultrasound Probe Covers?

The FDA product code for Sheathes Ultrasound Probe Covers is ITX.

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: ITX)

K260114Align® Cover and Pad Guidance ToolCIVCO Medical Instruments Co., Inc.K261170BA-004CCFujifilm Corporation K254143EM-TECH Passive Ultrasound Probe StrapEM-TECH Solutions, Inc.K260161SmartGuide Disposable Guides and GridsUC-CARE , Ltd.K262474ND Needle Guidance SystemAccurate Access, LLC K261014Accuro® 3S Needle Guide KitRivanna Medical, Inc.

Официальный источник

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