FDA 510(k)

Cianna Medical SAVI Scout Reflector and SAVI Scout System

Номер K: K161507 · 2016-07-29

Дата решения2016-07-29

Код продуктаPDW

Консультативный комитетSU

РешениеSubstantially Equivalent

Описание устройства

Cianna Medical SAVI Scout Reflector and SAVI Scout System is the device name listed in this FDA 510(k) record. The listed applicant is Cianna Medical, Inc.. It received FDA 510(k) clearance on 2016-07-29 under 510(k) number K161507. The device is classified under product code PDW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Cianna Medical SAVI Scout Reflector and SAVI Scout System?

Cianna Medical SAVI Scout Reflector and SAVI Scout System is a medical device that received FDA 510(k) clearance on 2016-07-29. The listed applicant is Cianna Medical, Inc.. The 510(k) number is K161507.

When did Cianna Medical SAVI Scout Reflector and SAVI Scout System receive FDA 510(k) clearance?

Cianna Medical SAVI Scout Reflector and SAVI Scout System received FDA 510(k) clearance on 2016-07-29, under 510(k) number K161507.

Who is the listed applicant for Cianna Medical SAVI Scout Reflector and SAVI Scout System?

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

What is the FDA product code for Cianna Medical SAVI Scout Reflector and SAVI Scout System?

The FDA product code for Cianna Medical SAVI Scout Reflector and SAVI Scout System is PDW.

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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Другие записи, где Cianna Medical, Inc. указан как заявитель

K181007Cianna Medical SAVI Scout Reflector and SAVI Scout System K171767Cianna Medical SAVI Scout Reflector and SAVI Scout System

Официальный источник

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