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FDA 510(k)

Neurodyn V2.0, Neurodyn Aussie V2.0

K-Number: K210572 · 2021-05-11

ApplicantIbramed Equipamentos Medicos
Decision Date2021-05-11
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Neurodyn V2.0, Neurodyn Aussie V2.0 is the device name listed in this FDA 510(k) record. The listed applicant is Ibramed Equipamentos Medicos. It received FDA 510(k) clearance on 2021-05-11 under 510(k) number K210572. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Neurodyn V2.0, Neurodyn Aussie V2.0?

Neurodyn V2.0, Neurodyn Aussie V2.0 is a medical device that received FDA 510(k) clearance on 2021-05-11. The listed applicant is Ibramed Equipamentos Medicos. The 510(k) number is K210572.

When did Neurodyn V2.0, Neurodyn Aussie V2.0 receive FDA 510(k) clearance?

Neurodyn V2.0, Neurodyn Aussie V2.0 received FDA 510(k) clearance on 2021-05-11, under 510(k) number K210572.

Who is the listed applicant for Neurodyn V2.0, Neurodyn Aussie V2.0?

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

What is the FDA product code for Neurodyn V2.0, Neurodyn Aussie V2.0?

The FDA product code for Neurodyn V2.0, Neurodyn Aussie V2.0 is IPF.

Related Devices (Code: IPF)

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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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