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FDA 510(k)

NeoGen PSR System

K-Number: K221873 · 2023-01-12

ApplicantEnergist Limited
Decision Date2023-01-12
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

NeoGen PSR System is a medical device manufactured by Energist Limited. It received FDA 510(k) clearance on 2023-01-12 under approval number K221873. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NeoGen PSR System?

NeoGen PSR System is a medical device that received FDA 510(k) clearance on 2023-01-12. It is manufactured by Energist Limited. The 510(k) number is K221873.

When was NeoGen PSR System approved by the FDA?

NeoGen PSR System received FDA 510(k) clearance on 2023-01-12, under approval number K221873.

What company makes NeoGen PSR System?

NeoGen PSR System is manufactured by Energist Limited.

What is the FDA product code for NeoGen PSR System?

The FDA product code for NeoGen PSR System is GEI.

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Official Source

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