FDA 510(k)

DizzyDoctor システム 1.0.0

K番号: K182214 · 2018-09-14

決定日2018-09-14

製品コードGWN

諮問委員会Please provide the source text to translate.

決定大幅同等

医療機器の概要

DizzyDoctor System 1.0.0 is the device name listed in this FDA 510(k) record. The listed applicant is Dizzydoctor Systems, LLC. It received FDA 510(k) clearance on 2018-09-14 under 510(k) number K182214. The device is classified under product code GWN. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the DizzyDoctor System 1.0.0?

DizzyDoctor System 1.0.0 is a medical device that received FDA 510(k) clearance on 2018-09-14. The listed applicant is Dizzydoctor Systems, LLC. The 510(k) number is K182214.

When did DizzyDoctor System 1.0.0 receive FDA 510(k) clearance?

DizzyDoctor System 1.0.0 received FDA 510(k) clearance on 2018-09-14, under 510(k) number K182214.

Who is the listed applicant for DizzyDoctor System 1.0.0?

The FDA 510(k) record lists Dizzydoctor Systems, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DizzyDoctor System 1.0.0?

The FDA product code for DizzyDoctor System 1.0.0 is GWN.

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DizzyDoctor システム 1.0.0

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：GWN）

公式ソース