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FDA 510(k)

优米森C1200,优米森C1200葡萄糖HK,钠电极,钾电极,氯电极

K号: K183375 · 2019-02-12

申请人Horiba, Ltd.
决定日期2019-02-12
产品代码JJE
咨询委员会CH 请注意,您提供的文本“CH”不足以进行翻译。请提供完整的医疗设备监管文本,以便我能够进行准确的翻译。
决定实质等同

器械摘要

Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, Chloride Electrode is the device name listed in this FDA 510(k) record. The listed applicant is Horiba, Ltd.. It received FDA 510(k) clearance on 2019-02-12 under 510(k) number K183375. The device is classified under product code JJE. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, Chloride Electrode?

Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, Chloride Electrode is a medical device that received FDA 510(k) clearance on 2019-02-12. The listed applicant is Horiba, Ltd.. The 510(k) number is K183375.

When did Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, Chloride Electrode receive FDA 510(k) clearance?

Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, Chloride Electrode received FDA 510(k) clearance on 2019-02-12, under 510(k) number K183375.

Who is the listed applicant for Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, Chloride Electrode?

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

What is the FDA product code for Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, Chloride Electrode?

The FDA product code for Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, Chloride Electrode is JJE.

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