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FDA 510(k)

EV Insite System

K-Number: K152716 · 2016-03-24

ApplicantPsp Corporation
Decision Date2016-03-24
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

EV Insite System is a medical device manufactured by Psp Corporation. It received FDA 510(k) clearance on 2016-03-24 under approval number K152716. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EV Insite System?

EV Insite System is a medical device that received FDA 510(k) clearance on 2016-03-24. It is manufactured by Psp Corporation. The 510(k) number is K152716.

When was EV Insite System approved by the FDA?

EV Insite System received FDA 510(k) clearance on 2016-03-24, under approval number K152716.

What company makes EV Insite System?

EV Insite System is manufactured by Psp Corporation.

What is the FDA product code for EV Insite System?

The FDA product code for EV Insite System is LLZ.

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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.

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