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FDA 510(k)

Neuro20 Pro System

K-Number: K223797 · 2023-02-23

ApplicantNeuro20 Technologies
Decision Date2023-02-23
Product CodeNGX
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Neuro20 Pro System is the device name listed in this FDA 510(k) record. The listed applicant is Neuro20 Technologies. It received FDA 510(k) clearance on 2023-02-23 under 510(k) number K223797. The device is classified under product code NGX. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Neuro20 Pro System?

Neuro20 Pro System is a medical device that received FDA 510(k) clearance on 2023-02-23. The listed applicant is Neuro20 Technologies. The 510(k) number is K223797.

When did Neuro20 Pro System receive FDA 510(k) clearance?

Neuro20 Pro System received FDA 510(k) clearance on 2023-02-23, under 510(k) number K223797.

Who is the listed applicant for Neuro20 Pro System?

The FDA 510(k) record lists Neuro20 Technologies as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Neuro20 Pro System?

The FDA product code for Neuro20 Pro System is NGX.

Related Devices (Code: NGX)

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.

K253790High Intensity Focused Electromagnetic Stimulation Device (FE60)Beijing Winkonlaser Technology LimitedK253926DiacoreShenB Co., Ltd.K253636Zionic Pro Max (EMS)Termosalud S.L.K253408CoolToneZimmer Medizinsysteme GmbHK252154Portable Electro Stimulation Therapy Device (LGT-2320BE, LGT-2320ME, and LGT-2320SP)Guangzhou Longest Medical Technology Co., Ltd.K253478Motive™ Muscle Stimulator for Lower Back (OT01-1003)Motive Health, Inc.

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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