FDA 510(k)

Body Pro-Lok Respiratory Plate, Respiratory Plate Cushion, Body Pro-Respiratory Belt, Rail Clamp for Respiratory Belt, Pressure Gauge Replacement

Номер K: K153026 · 2016-05-25

ЗаявительMedtec, Inc. D/B/A Civco Medical Solutions

Дата решения2016-05-25

Код продуктаIYE

Консультативный комитетRA

РешениеSubstantially Equivalent

Описание устройства

Body Pro-Lok Respiratory Plate, Respiratory Plate Cushion, Body Pro-Respiratory Belt, Rail Clamp for Respiratory Belt, Pressure Gauge Replacement is the device name listed in this FDA 510(k) record. The listed applicant is Medtec, Inc. D/B/A Civco Medical Solutions. It received FDA 510(k) clearance on 2016-05-25 under 510(k) number K153026. 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 Body Pro-Lok Respiratory Plate, Respiratory Plate Cushion, Body Pro-Respiratory Belt, Rail Clamp for Respiratory Belt, Pressure Gauge Replacement?

Body Pro-Lok Respiratory Plate, Respiratory Plate Cushion, Body Pro-Respiratory Belt, Rail Clamp for Respiratory Belt, Pressure Gauge Replacement is a medical device that received FDA 510(k) clearance on 2016-05-25. The listed applicant is Medtec, Inc. D/B/A Civco Medical Solutions. The 510(k) number is K153026.

When did Body Pro-Lok Respiratory Plate, Respiratory Plate Cushion, Body Pro-Respiratory Belt, Rail Clamp for Respiratory Belt, Pressure Gauge Replacement receive FDA 510(k) clearance?

Body Pro-Lok Respiratory Plate, Respiratory Plate Cushion, Body Pro-Respiratory Belt, Rail Clamp for Respiratory Belt, Pressure Gauge Replacement received FDA 510(k) clearance on 2016-05-25, under 510(k) number K153026.

Who is the listed applicant for Body Pro-Lok Respiratory Plate, Respiratory Plate Cushion, Body Pro-Respiratory Belt, Rail Clamp for Respiratory Belt, Pressure Gauge Replacement?

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

What is the FDA product code for Body Pro-Lok Respiratory Plate, Respiratory Plate Cushion, Body Pro-Respiratory Belt, Rail Clamp for Respiratory Belt, Pressure Gauge Replacement?

The FDA product code for Body Pro-Lok Respiratory Plate, Respiratory Plate Cushion, Body Pro-Respiratory Belt, Rail Clamp for Respiratory Belt, Pressure Gauge Replacement 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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