FDA 510(k)

STERRAD VELOCITY 生物指標

K番号: K182404 · 2018-12-27

申請者Advanced Sterilization Products (Asp)

決定日2018-12-27

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 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 2018-12-27 under 510(k) number K182404. 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?

STERRAD VELOCITY Biological Indicator is a medical device that received FDA 510(k) clearance on 2018-12-27. The listed applicant is Advanced Sterilization Products (Asp). The 510(k) number is K182404.

When did STERRAD VELOCITY Biological Indicator receive FDA 510(k) clearance?

STERRAD VELOCITY Biological Indicator received FDA 510(k) clearance on 2018-12-27, under 510(k) number K182404.

Who is the listed applicant for STERRAD VELOCITY Biological Indicator?

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?

The FDA product code for STERRAD VELOCITY Biological Indicator is FRC.

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

K192025STERRAD VELOCITY 生物標示器/プロセス挑戦装置およびリーダー 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 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

FDAデータベースで見る →

データはFDA Open APIから取得しています。最新かつ権威ある情報については、常に公式レコードを参照してください。