FDA 510(k)

Philips Biosensor BX100

K号: K192875 · 2020-04-16

决定日期2020-04-16

产品代码DRG

咨询委员会CV 请注意，由于原文未提供具体内容，以下是一个示例翻译： --- 产品名称：[产品名称] 公司名称：[公司名称] FDA批准号：[FDA批准号] 510(k)申请号：[510(k)申请号] PMA申请号：[PMA申请号] 临床试验注册号：[NCT] PubMed ID：[PMID] 产品标识符：[标识符] 产品URL：[URL] --- 请将上述示例中的[产品名称]、[公司名称]、[FDA批准号]等占位符替换为实际内容。

决定实质等同

器械摘要

Philips Biosensor BX100 is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems. It received FDA 510(k) clearance on 2020-04-16 under 510(k) number K192875. The device is classified under product code DRG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Philips Biosensor BX100?

Philips Biosensor BX100 is a medical device that received FDA 510(k) clearance on 2020-04-16. The listed applicant is Philips Medical Systems. The 510(k) number is K192875.

When did Philips Biosensor BX100 receive FDA 510(k) clearance?

Philips Biosensor BX100 received FDA 510(k) clearance on 2020-04-16, under 510(k) number K192875.

Who is the listed applicant for Philips Biosensor BX100?

The FDA 510(k) record lists Philips Medical Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Philips Biosensor BX100?

The FDA product code for Philips Biosensor BX100 is DRG.

列明Philips Medical Systems为申报人的其他记录

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