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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 the device name listed in this FDA 510(k) record. The listed applicant is Neuromodulatory Devices & Applications. It received FDA 510(k) clearance on 2025-02-13 under 510(k) 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. The listed applicant is Neuromodulatory Devices & Applications. The 510(k) number is K243319.

When did Ampa One System (AMPA-001) receive FDA 510(k) clearance?

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

Who is the listed applicant for Ampa One System (AMPA-001)?

The FDA 510(k) record lists Neuromodulatory Devices & Applications as the applicant. This does not by itself establish the device manufacturer.

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 records listing Neuromodulatory Devices & Applications as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251210Ampa One System (AMPA-001)

Related Devices (Code: OBP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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