FDA 510(k)

Bolt Navigation System

Номер K: K213768 · 2022-12-01

ЗаявительCircinus Medical Technology, LLC

Дата решения2022-12-01

Код продуктаOWB

Консультативный комитетRA

РешениеSubstantially Equivalent

Описание устройства

Bolt Navigation System is the device name listed in this FDA 510(k) record. The listed applicant is Circinus Medical Technology, LLC. It received FDA 510(k) clearance on 2022-12-01 under 510(k) number K213768. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Bolt Navigation System?

Bolt Navigation System is a medical device that received FDA 510(k) clearance on 2022-12-01. The listed applicant is Circinus Medical Technology, LLC. The 510(k) number is K213768.

When did Bolt Navigation System receive FDA 510(k) clearance?

Bolt Navigation System received FDA 510(k) clearance on 2022-12-01, under 510(k) number K213768.

Who is the listed applicant for Bolt Navigation System?

The FDA 510(k) record lists Circinus Medical Technology, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Bolt Navigation System?

The FDA product code for Bolt Navigation System is OWB.

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: OWB)

K253726uAngio AVIVA CXShanghai United Imaging Healthcare Co., Ltd.K261413EXTRON 3;EXTRON 6DRTECH Corporation K254205Zenition 30Philips Medical Systems Nederland B.V.K260607Shield System (Siemens 30x40)Radiaction , Ltd.K253670SmartCT (R3.0 (L10))Philips Medical Systems B.V.K252735C-beamPulmera, Inc.

Официальный источник

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