FDA 510(k)

Philips BlueControl

K-Number: K171055 · 2017-07-06

ApplicantPhilips Electronics Nederland B.V.

Decision Date2017-07-06

Product CodeONE

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Other records listing Philips Electronics Nederland B.V. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K192259Philips IntelliSite Pathology Solution

Related Devices (Code: ONE)

K250224handLITE (TN19S)iSMART Developments, Ltd.

Official Source

View on FDA Database →

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