FDA 510(k)

ルミネル DTx 子宮鏡システム、ルミネル 360 旋回可能無菌 disposable シート強度

K番号: K190827 · 2019-06-06

決定日2019-06-06

製品コードHIH

諮問委員会医薬品機器規制テキストの翻訳は以下の通りです。 [原文] OB [翻訳] OB

決定Substantially Equivalent

医療機器の概要

Luminelle DTx Hysteroscopy System, Luminelle 360 Rotatable Sterile Disposable Sheath Rigid is the device name listed in this FDA 510(k) record. The listed applicant is Uvision360, Inc.. It received FDA 510(k) clearance on 2019-06-06 under 510(k) number K190827. The device is classified under product code HIH. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Luminelle DTx Hysteroscopy System, Luminelle 360 Rotatable Sterile Disposable Sheath Rigid?

Luminelle DTx Hysteroscopy System, Luminelle 360 Rotatable Sterile Disposable Sheath Rigid is a medical device that received FDA 510(k) clearance on 2019-06-06. The listed applicant is Uvision360, Inc.. The 510(k) number is K190827.

When did Luminelle DTx Hysteroscopy System, Luminelle 360 Rotatable Sterile Disposable Sheath Rigid receive FDA 510(k) clearance?

Luminelle DTx Hysteroscopy System, Luminelle 360 Rotatable Sterile Disposable Sheath Rigid received FDA 510(k) clearance on 2019-06-06, under 510(k) number K190827.

Who is the listed applicant for Luminelle DTx Hysteroscopy System, Luminelle 360 Rotatable Sterile Disposable Sheath Rigid?

The FDA 510(k) record lists Uvision360, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Luminelle DTx Hysteroscopy System, Luminelle 360 Rotatable Sterile Disposable Sheath Rigid?

The FDA product code for Luminelle DTx Hysteroscopy System, Luminelle 360 Rotatable Sterile Disposable Sheath Rigid is HIH.

申請者としてUvision360, Inc.を記載するその他の記録

K210512LUMINELLE DTx システム K192278Luminelle DTx 子宮鏡システム、Luminelle Dx 360 旋回式 disposable シート（診断用）K181909Luminelle DTx 子宮鏡システム

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