FDA 510(k)

AEROFLEX™ 自動內鏡再處理器配 AUTOSURE™ MRC 監視器

K 號：K181472 · 2019-04-23

申請人Advanced Sterilization Products (Asp)

決定日期2019-04-23

產品代碼FEB

諮詢委員會GU

決定相當於

器材摘要

AEROFLEX(TM) Automatic Endoscope Reprocessor with AUTOSURE(TM) MRC Monitor 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 2019-04-23 under 510(k) number K181472. The device is classified under product code FEB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the AEROFLEX(TM) Automatic Endoscope Reprocessor with AUTOSURE(TM) MRC Monitor?

AEROFLEX(TM) Automatic Endoscope Reprocessor with AUTOSURE(TM) MRC Monitor is a medical device that received FDA 510(k) clearance on 2019-04-23. The listed applicant is Advanced Sterilization Products (Asp). The 510(k) number is K181472.

When did AEROFLEX(TM) Automatic Endoscope Reprocessor with AUTOSURE(TM) MRC Monitor receive FDA 510(k) clearance?

AEROFLEX(TM) Automatic Endoscope Reprocessor with AUTOSURE(TM) MRC Monitor received FDA 510(k) clearance on 2019-04-23, under 510(k) number K181472.

Who is the listed applicant for AEROFLEX(TM) Automatic Endoscope Reprocessor with AUTOSURE(TM) MRC Monitor?

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 AEROFLEX(TM) Automatic Endoscope Reprocessor with AUTOSURE(TM) MRC Monitor?

The FDA product code for AEROFLEX(TM) Automatic Endoscope Reprocessor with AUTOSURE(TM) MRC Monitor is FEB.

其他以 Advanced Sterilization Products (Asp) 為申請人之記錄

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