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FDA 510(k)

Philips BlueControl

K-Number: K171055 · 2017-07-06

Decision Date2017-07-06
Product CodeONE
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

What is the Philips BlueControl?

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

When was Philips BlueControl approved by the FDA?

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

What company makes Philips BlueControl?

Philips BlueControl is manufactured by Philips Electronics Nederland B.V..

What is the FDA product code for Philips BlueControl?

The FDA product code for Philips BlueControl is ONE.

Other Devices by Philips Electronics Nederland B.V.

Related Devices (Code: ONE)

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.