FDA 510(k)

STURDY Autoclave Super Microm（モデルSA-260MAおよびSA-260MA-R）

K番号: K181993 · 2019-11-01

決定日2019-11-01

製品コードFLE

諮問委員会医療機器規制テキストの翻訳は以下の通りです。 HO [翻訳が提供されなかったため、原文の「HO」がそのまま使用されます]

決定大幅同等

医療機器の概要

STURDY Autoclave Super Microm (models SA-260MA and SA-260MA-R) is the device name listed in this FDA 510(k) record. The listed applicant is Sturdy Industrial Co., Ltd.. It received FDA 510(k) clearance on 2019-11-01 under 510(k) number K181993. The device is classified under product code FLE. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the STURDY Autoclave Super Microm (models SA-260MA and SA-260MA-R)?

STURDY Autoclave Super Microm (models SA-260MA and SA-260MA-R) is a medical device that received FDA 510(k) clearance on 2019-11-01. The listed applicant is Sturdy Industrial Co., Ltd.. The 510(k) number is K181993.

When did STURDY Autoclave Super Microm (models SA-260MA and SA-260MA-R) receive FDA 510(k) clearance?

STURDY Autoclave Super Microm (models SA-260MA and SA-260MA-R) received FDA 510(k) clearance on 2019-11-01, under 510(k) number K181993.

Who is the listed applicant for STURDY Autoclave Super Microm (models SA-260MA and SA-260MA-R)?

The FDA 510(k) record lists Sturdy Industrial Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STURDY Autoclave Super Microm (models SA-260MA and SA-260MA-R)?

The FDA product code for STURDY Autoclave Super Microm (models SA-260MA and SA-260MA-R) is FLE.

申請者としてSturdy Industrial Co., Ltd.を記載するその他の記録

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