FDA 510(k)

Blustone Synergy Silica System

Номер K: K172330 · 2017-12-21

Дата решения2017-12-21

Код продуктаMQP

Консультативный комитетOR

РешениеSubstantially Equivalent

Описание устройства

Blustone Synergy Silica System is the device name listed in this FDA 510(k) record. The listed applicant is Blustone Synergy. It received FDA 510(k) clearance on 2017-12-21 under 510(k) number K172330. The device is classified under product code MQP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Blustone Synergy Silica System?

Blustone Synergy Silica System is a medical device that received FDA 510(k) clearance on 2017-12-21. The listed applicant is Blustone Synergy. The 510(k) number is K172330.

When did Blustone Synergy Silica System receive FDA 510(k) clearance?

Blustone Synergy Silica System received FDA 510(k) clearance on 2017-12-21, under 510(k) number K172330.

Who is the listed applicant for Blustone Synergy Silica System?

The FDA 510(k) record lists Blustone Synergy as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Blustone Synergy Silica System?

The FDA product code for Blustone Synergy Silica System is MQP.

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: MQP)

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Официальный источник

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