FDA 510(k)

FlowStar Touch數位混合流量計

K 號：K222794 · 2023-07-28

決定日期2023-07-28

產品代碼BZR

諮詢委員會AN

決定相當於

器材摘要

FlowStar Touch Digital Mixer Flowmeter is the device name listed in this FDA 510(k) record. The listed applicant is Baldus Sedation GmbH & Co. KG. It received FDA 510(k) clearance on 2023-07-28 under 510(k) number K222794. The device is classified under product code BZR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the FlowStar Touch Digital Mixer Flowmeter?

FlowStar Touch Digital Mixer Flowmeter is a medical device that received FDA 510(k) clearance on 2023-07-28. The listed applicant is Baldus Sedation GmbH & Co. KG. The 510(k) number is K222794.

When did FlowStar Touch Digital Mixer Flowmeter receive FDA 510(k) clearance?

FlowStar Touch Digital Mixer Flowmeter received FDA 510(k) clearance on 2023-07-28, under 510(k) number K222794.

Who is the listed applicant for FlowStar Touch Digital Mixer Flowmeter?

The FDA 510(k) record lists Baldus Sedation GmbH & Co. KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FlowStar Touch Digital Mixer Flowmeter?

The FDA product code for FlowStar Touch Digital Mixer Flowmeter is BZR.

其他以 Baldus Sedation GmbH & Co. KG 為申請人之記錄

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K230987FlowStar 模擬混合流量計

相關器械（代碼：BZR）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K243917F&P Optiflow 氧氣/空氣流量來源Fisher & Paykel Healthcare, Ltd.K241465米達流量計；電子自動化測量系統Parker Hannifin Corporation K231895Maxtec MaxBlend2+p 医療設備規範文本翻譯： Maxtec MaxBlend2+p 医療設備規範文本Maxtec, LLC K230987FlowStar 模擬混合流量計Baldus Sedation GmbH & Co. KG K221494品質混合攪拌機，氧氣攪拌機Dehas Medical Systems GmbH K202480尼特羅克斯 Plus 0-70，尼特羅克斯 0-50，尼特羅克斯 Plus 50/50Parker Hannifin

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