Decision Date2023-04-11
Product CodeGZF
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
Neuspera Nuity System is a medical device manufactured by Neuspera Medical, Inc.. It received FDA 510(k) clearance on 2023-04-11 under approval number K221303. The device is classified under product code GZF. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Neuspera Nuity System?
Neuspera Nuity System is a medical device that received FDA 510(k) clearance on 2023-04-11. It is manufactured by Neuspera Medical, Inc.. The 510(k) number is K221303.
When was Neuspera Nuity System approved by the FDA?
Neuspera Nuity System received FDA 510(k) clearance on 2023-04-11, under approval number K221303.
What company makes Neuspera Nuity System?
Neuspera Nuity System is manufactured by Neuspera Medical, Inc..
What is the FDA product code for Neuspera Nuity System?
The FDA product code for Neuspera Nuity System is GZF.
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Official Source
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