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FDA 510(k), K221303, Neuspera Nuity System
FDA 510(k), K221303, Neuspera Nuity System
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510(K) Number: K221303
Device Name: Neuspera Nuity System
Manufacturer: Alexander Yeh
Device Classification Name: Stimulator, Peripheral Nerve, Implanted (Pain Relief)
Regulation Number: GZF
Classification Product Code: 05/05/2022
Date Received: 04/11/2023
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Neurology
Device Name: Neuspera Nuity System
Manufacturer: Alexander Yeh
Device Classification Name: Stimulator, Peripheral Nerve, Implanted (Pain Relief)
Regulation Number: GZF
Classification Product Code: 05/05/2022
Date Received: 04/11/2023
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Neurology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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