FDA 510(k)

TOTIM患者固定クッションシステム

K番号: K190894 · 2019-04-30

決定日2019-04-30

製品コードIYE

諮問委員会RA （注：由于原文中未提供具体的医疗设备监管文本内容，因此无法进行翻译。请提供具体的文本内容以便进行翻译。）

決定大幅同等

医療機器の概要

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.

よくある質問

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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TOTIM患者固定クッションシステム

医療機器の概要

よくある質問

関連する臨床試験

関連機器（コード：IYE）

公式ソース