FDA 510(k)

Ampa One System (AMPA-001)

K-Number: K243319 · 2025-02-13

ApplicantNeuromodulatory Devices & Applications

Decision Date2025-02-13

Product CodeOBP

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

Ampa One System (AMPA-001) is a medical device manufactured by Neuromodulatory Devices & Applications. It received FDA 510(k) clearance on 2025-02-13 under approval number K243319. The device is classified under product code OBP. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Ampa One System (AMPA-001)?

Ampa One System (AMPA-001) is a medical device that received FDA 510(k) clearance on 2025-02-13. It is manufactured by Neuromodulatory Devices & Applications. The 510(k) number is K243319.

When was Ampa One System (AMPA-001) approved by the FDA?

Ampa One System (AMPA-001) received FDA 510(k) clearance on 2025-02-13, under approval number K243319.

What company makes Ampa One System (AMPA-001)?

Ampa One System (AMPA-001) is manufactured by Neuromodulatory Devices & Applications.

What is the FDA product code for Ampa One System (AMPA-001)?

The FDA product code for Ampa One System (AMPA-001) is OBP.

Other Devices by Neuromodulatory Devices & Applications

K251210Ampa One System (AMPA-001)

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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.