FDA 510(k)

STERRAD 100NX セルフクリア技術搭載滅菌器

K番号: K212174 · 2021-10-09

申請者Advanced Sterilization Products, Inc.

決定日2021-10-09

製品コードMLR

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 100NX Sterilizer with ALLClear Technology is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Sterilization Products, Inc.. It received FDA 510(k) clearance on 2021-10-09 under 510(k) number K212174. The device is classified under product code MLR. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the STERRAD 100NX Sterilizer with ALLClear Technology?

STERRAD 100NX Sterilizer with ALLClear Technology is a medical device that received FDA 510(k) clearance on 2021-10-09. The listed applicant is Advanced Sterilization Products, Inc.. The 510(k) number is K212174.

When did STERRAD 100NX Sterilizer with ALLClear Technology receive FDA 510(k) clearance?

STERRAD 100NX Sterilizer with ALLClear Technology received FDA 510(k) clearance on 2021-10-09, under 510(k) number K212174.

Who is the listed applicant for STERRAD 100NX Sterilizer with ALLClear Technology?

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

What is the FDA product code for STERRAD 100NX Sterilizer with ALLClear Technology?

The FDA product code for STERRAD 100NX Sterilizer with ALLClear Technology is MLR.

申請者としてAdvanced Sterilization Products, Inc.を記載するその他の記録

K252843STERRAD 100NX 消毒システム with ALLClear テクノロジー（10104）K250802STERRAD® 100NX 消毒器すべての清浄技術（10104）K234084STERRAD™化学指示器（CI）ストリップ（14100）；STERRAD® SEALSURE®化学指示器（CI）テープ（14202NL）；STERRAD VELOCITY™生物指示器（BI）（43210）（60個）；STERRAD VELOCITY™生物指示器（BI）（43210-30）（30個）；STERRAD VELOCITY™リーダー（43220）；ULTRA GI™プロセス挑戦デバイス（PCD）（43400）（30個）K220404STERRAD NX に ALLClear テクノロジーを搭載

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