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FDA 510(k)

NeuroRPM

K-Number: K221772 · 2023-03-17

ApplicantNew Touch Digital, Inc.
Decision Date2023-03-17
Product CodeGYD
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NeuroRPM is a medical device manufactured by New Touch Digital, Inc.. It received FDA 510(k) clearance on 2023-03-17 under approval number K221772. The device is classified under product code GYD. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NeuroRPM?

NeuroRPM is a medical device that received FDA 510(k) clearance on 2023-03-17. It is manufactured by New Touch Digital, Inc.. The 510(k) number is K221772.

When was NeuroRPM approved by the FDA?

NeuroRPM received FDA 510(k) clearance on 2023-03-17, under approval number K221772.

What company makes NeuroRPM?

NeuroRPM is manufactured by New Touch Digital, Inc..

What is the FDA product code for NeuroRPM?

The FDA product code for NeuroRPM is GYD.

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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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