FDA 510(k)

TOTIM Patient Cushion Immobilization System

Número K: K190894 · 2019-04-30

Data da decisão2019-04-30

Código do produtoIYE

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

TOTIM Patient Cushion Immobilization System is the device name listed in this FDA 510(k) record. The listed applicant is Essebi Medical Srl. It received FDA 510(k) clearance on 2019-04-30 under 510(k) number K190894. 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 TOTIM Patient Cushion Immobilization System?

TOTIM Patient Cushion Immobilization System is a medical device that received FDA 510(k) clearance on 2019-04-30. The listed applicant is Essebi Medical Srl. The 510(k) number is K190894.

When did TOTIM Patient Cushion Immobilization System receive FDA 510(k) clearance?

TOTIM Patient Cushion Immobilization System received FDA 510(k) clearance on 2019-04-30, under 510(k) number K190894.

Who is the listed applicant for TOTIM Patient Cushion Immobilization System?

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

What is the FDA product code for TOTIM Patient Cushion Immobilization System?

The FDA product code for TOTIM Patient Cushion Immobilization System is IYE.

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