FDA 510(k)

Solstice SRS Immobilization System; Solstat Immobilization System; Solstice Thermoplastic Mask

Номер K: K182079 · 2018-09-07

ЗаявительMedtec Inc. Dba Civco Medical Solutions

Дата решения2018-09-07

Код продуктаIYE

Консультативный комитетRA

РешениеSubstantially Equivalent

Описание устройства

Solstice SRS Immobilization System; Solstat Immobilization System; Solstice Thermoplastic Mask is the device name listed in this FDA 510(k) record. The listed applicant is Medtec Inc. Dba Civco Medical Solutions. It received FDA 510(k) clearance on 2018-09-07 under 510(k) number K182079. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Solstice SRS Immobilization System; Solstat Immobilization System; Solstice Thermoplastic Mask?

Solstice SRS Immobilization System; Solstat Immobilization System; Solstice Thermoplastic Mask is a medical device that received FDA 510(k) clearance on 2018-09-07. The listed applicant is Medtec Inc. Dba Civco Medical Solutions. The 510(k) number is K182079.

When did Solstice SRS Immobilization System; Solstat Immobilization System; Solstice Thermoplastic Mask receive FDA 510(k) clearance?

Solstice SRS Immobilization System; Solstat Immobilization System; Solstice Thermoplastic Mask received FDA 510(k) clearance on 2018-09-07, under 510(k) number K182079.

Who is the listed applicant for Solstice SRS Immobilization System; Solstat Immobilization System; Solstice Thermoplastic Mask?

The FDA 510(k) record lists Medtec Inc. Dba Civco Medical Solutions as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Solstice SRS Immobilization System; Solstat Immobilization System; Solstice Thermoplastic Mask?

The FDA product code for Solstice SRS Immobilization System; Solstat Immobilization System; Solstice Thermoplastic Mask is IYE.

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: IYE)

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Официальный источник

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