FDA 510(k)

リゾンド・アコースティック・ドライバー・システム

K番号: K201389 · 2020-07-10

決定日2020-07-10

製品コードLNH

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

Resoundant Acoustic Driver System is the device name listed in this FDA 510(k) record. The listed applicant is Resoundant, Inc.. It received FDA 510(k) clearance on 2020-07-10 under 510(k) number K201389. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Resoundant Acoustic Driver System?

Resoundant Acoustic Driver System is a medical device that received FDA 510(k) clearance on 2020-07-10. The listed applicant is Resoundant, Inc.. The 510(k) number is K201389.

When did Resoundant Acoustic Driver System receive FDA 510(k) clearance?

Resoundant Acoustic Driver System received FDA 510(k) clearance on 2020-07-10, under 510(k) number K201389.

Who is the listed applicant for Resoundant Acoustic Driver System?

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

What is the FDA product code for Resoundant Acoustic Driver System?

The FDA product code for Resoundant Acoustic Driver System is LNH.

申請者としてResoundant, Inc.を記載するその他の記録

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