FDA 510(k)

レルテック超音波画像システム（モデル：LU700シリーズ）

K番号: K222365 · 2022-10-25

決定日2022-10-25

製品コードIYN

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Substantially Equivalent

医療機器の概要

Leltek Ultrasound Imaging System (Model: LU700 Series) is the device name listed in this FDA 510(k) record. The listed applicant is Leltek, Inc.. It received FDA 510(k) clearance on 2022-10-25 under 510(k) number K222365. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Leltek Ultrasound Imaging System (Model: LU700 Series)?

Leltek Ultrasound Imaging System (Model: LU700 Series) is a medical device that received FDA 510(k) clearance on 2022-10-25. The listed applicant is Leltek, Inc.. The 510(k) number is K222365.

When did Leltek Ultrasound Imaging System (Model: LU700 Series) receive FDA 510(k) clearance?

Leltek Ultrasound Imaging System (Model: LU700 Series) received FDA 510(k) clearance on 2022-10-25, under 510(k) number K222365.

Who is the listed applicant for Leltek Ultrasound Imaging System (Model: LU700 Series)?

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

What is the FDA product code for Leltek Ultrasound Imaging System (Model: LU700 Series)?

The FDA product code for Leltek Ultrasound Imaging System (Model: LU700 Series) is IYN.

申請者としてLeltek, Inc.を記載するその他の記録

公式ソース

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