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FDA 510(k)

Stimuplex Onvision System

K-Number: K192914 · 2020-05-27

Decision Date2020-05-27
Product CodeBSP
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Stimuplex Onvision System is a medical device manufactured by Philips Medical Systems Nederland B.V.. It received FDA 510(k) clearance on 2020-05-27 under approval 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. It is manufactured by Philips Medical Systems Nederland B.V.. The 510(k) number is K192914.

When was Stimuplex Onvision System approved by the FDA?

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

What company makes Stimuplex Onvision System?

Stimuplex Onvision System is manufactured by Philips Medical Systems Nederland B.V..

What is the FDA product code for Stimuplex Onvision System?

The FDA product code for Stimuplex Onvision System is BSP.

Other Devices by Philips Medical Systems Nederland B.V.

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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.