s LDL-EX SEIKEN
K号: K161679 · 2017-08-18
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决定日期2017-08-18
产品代码PYP
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
s LDL-EX SEIKEN is the device name listed in this FDA 510(k) record. The listed applicant is Denka Seiken Co., Ltd.. It received FDA 510(k) clearance on 2017-08-18 under 510(k) number K161679. The device is classified under product code PYP. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the s LDL-EX SEIKEN?
s LDL-EX SEIKEN is a medical device that received FDA 510(k) clearance on 2017-08-18. The listed applicant is Denka Seiken Co., Ltd.. The 510(k) number is K161679.
When did s LDL-EX SEIKEN receive FDA 510(k) clearance?
s LDL-EX SEIKEN received FDA 510(k) clearance on 2017-08-18, under 510(k) number K161679.
Who is the listed applicant for s LDL-EX SEIKEN?
The FDA 510(k) record lists Denka Seiken Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for s LDL-EX SEIKEN?
The FDA product code for s LDL-EX SEIKEN is PYP.
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官方来源
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