FDA 510(k)

Philips BlueControl

K号: K171055 · 2017-07-06

决定日期2017-07-06

产品代码ONE

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决定实质等同

器械摘要

Philips BlueControl is the device name listed in this FDA 510(k) record. The listed applicant is Philips Electronics Nederland B.V.. It received FDA 510(k) clearance on 2017-07-06 under 510(k) number K171055. The device is classified under product code ONE. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Philips BlueControl?

Philips BlueControl is a medical device that received FDA 510(k) clearance on 2017-07-06. The listed applicant is Philips Electronics Nederland B.V.. The 510(k) number is K171055.

When did Philips BlueControl receive FDA 510(k) clearance?

Philips BlueControl received FDA 510(k) clearance on 2017-07-06, under 510(k) number K171055.

Who is the listed applicant for Philips BlueControl?

The FDA 510(k) record lists Philips Electronics Nederland B.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Philips BlueControl?

The FDA product code for Philips BlueControl is ONE.

列明Philips Electronics Nederland B.V.为申报人的其他记录

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