FDA 510(k)

自立型生物指標

K番号: K200970 · 2020-12-28

決定日2020-12-28

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

Self-Contained Biological Indicator is the device name listed in this FDA 510(k) record. The listed applicant is True Indicating, LLC. It received FDA 510(k) clearance on 2020-12-28 under 510(k) number K200970. 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 Self-Contained Biological Indicator?

Self-Contained Biological Indicator is a medical device that received FDA 510(k) clearance on 2020-12-28. The listed applicant is True Indicating, LLC. The 510(k) number is K200970.

When did Self-Contained Biological Indicator receive FDA 510(k) clearance?

Self-Contained Biological Indicator received FDA 510(k) clearance on 2020-12-28, under 510(k) number K200970.

Who is the listed applicant for Self-Contained Biological Indicator?

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

What is the FDA product code for Self-Contained Biological Indicator?

The FDA product code for Self-Contained Biological Indicator is FRC.

申請者としてTrue Indicating, LLCを記載するその他の記録

K251559インスタTRUE スチーム用即時生物学的指標（IBI-05）K242860蒸気（CSPN-15）用統合インジケーター Type 5 K233413ウルトラフォン化学指示器（TRO-TおよびTRO-B）K220778蒸気用化学指示器 K210481即時20秒インディケーター

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