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FDA 510(k)

Stimuplex Onvision System

K-Number: K192914 · 2020-05-27

ApplicantPhilips Medical Systems Nederland B.V.
Decision Date2020-05-27
Product CodeBSP
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Stimuplex Onvision System is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems Nederland B.V.. It received FDA 510(k) clearance on 2020-05-27 under 510(k) number K192914. The device is classified under product code BSP. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Stimuplex Onvision System?

Stimuplex Onvision System is a medical device that received FDA 510(k) clearance on 2020-05-27. The listed applicant is Philips Medical Systems Nederland B.V.. The 510(k) number is K192914.

When did Stimuplex Onvision System receive FDA 510(k) clearance?

Stimuplex Onvision System received FDA 510(k) clearance on 2020-05-27, under 510(k) number K192914.

Who is the listed applicant for Stimuplex Onvision System?

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

What is the FDA product code for Stimuplex Onvision System?

The FDA product code for Stimuplex Onvision System is BSP.

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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.

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