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FDA 510(k)

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

Número K: K153026 · 2016-05-25

RequerenteMedtec, Inc. D/B/A Civco Medical Solutions
Data da decisão2016-05-25
Código do produtoIYE
Comité consultivoRA
DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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.

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