FDA 510(k)

STERRAD VELOCITY 生物標示器/プロセス挑戦装置およびリーダー

K番号: K192025 · 2020-01-23

申請者Advanced Sterilization Products (Asp)

決定日2020-01-23

製品コードFRC

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

STERRAD VELOCITY Biological Indicator/Process Challenge Device and Reader is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Sterilization Products (Asp). It received FDA 510(k) clearance on 2020-01-23 under 510(k) number K192025. The device is classified under product code FRC. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the STERRAD VELOCITY Biological Indicator/Process Challenge Device and Reader?

STERRAD VELOCITY Biological Indicator/Process Challenge Device and Reader is a medical device that received FDA 510(k) clearance on 2020-01-23. The listed applicant is Advanced Sterilization Products (Asp). The 510(k) number is K192025.

When did STERRAD VELOCITY Biological Indicator/Process Challenge Device and Reader receive FDA 510(k) clearance?

STERRAD VELOCITY Biological Indicator/Process Challenge Device and Reader received FDA 510(k) clearance on 2020-01-23, under 510(k) number K192025.

Who is the listed applicant for STERRAD VELOCITY Biological Indicator/Process Challenge Device and Reader?

The FDA 510(k) record lists Advanced Sterilization Products (Asp) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STERRAD VELOCITY Biological Indicator/Process Challenge Device and Reader?

The FDA product code for STERRAD VELOCITY Biological Indicator/Process Challenge Device and Reader is FRC.

申請者としてAdvanced Sterilization Products (Asp)を記載するその他の記録

K181472AEROFLEX™オートマチック内視鏡再処理装置およびAUTOSURE™MRCモニター K182404STERRAD VELOCITY 生物指標 K170039STERRAD VELOCITY 生物指標およびリーダー K152189エボテック ECR

公式ソース

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