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FDA 510(k)

SignalNED System (Model RE)

K-Number: K251726 · 2025-09-03

ApplicantForest Devices, Inc.
Decision Date2025-09-03
Product CodeOMC
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SignalNED System (Model RE) is a medical device manufactured by Forest Devices, Inc.. It received FDA 510(k) clearance on 2025-09-03 under approval number K251726. The device is classified under product code OMC. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SignalNED System (Model RE)?

SignalNED System (Model RE) is a medical device that received FDA 510(k) clearance on 2025-09-03. It is manufactured by Forest Devices, Inc.. The 510(k) number is K251726.

When was SignalNED System (Model RE) approved by the FDA?

SignalNED System (Model RE) received FDA 510(k) clearance on 2025-09-03, under approval number K251726.

What company makes SignalNED System (Model RE)?

SignalNED System (Model RE) is manufactured by Forest Devices, Inc..

What is the FDA product code for SignalNED System (Model RE)?

The FDA product code for SignalNED System (Model RE) is OMC.

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Other Devices by Forest Devices, Inc.

K242306SignalNED System (Model RE)

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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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