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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 the device name listed in this FDA 510(k) record. The listed applicant is Forest Devices, Inc.. It received FDA 510(k) clearance on 2025-09-03 under 510(k) 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. The listed applicant is Forest Devices, Inc.. The 510(k) number is K251726.

When did SignalNED System (Model RE) receive FDA 510(k) clearance?

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

Who is the listed applicant for SignalNED System (Model RE)?

The FDA 510(k) record lists Forest Devices, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Forest Devices, Inc. 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.

K242306SignalNED System (Model RE)

Related Devices (Code: OMC)

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.

K261101Ceribell MonitorCeribell, Inc.K251550NX01 (NX01)Naox Technologies SasK243185REMI Remote EEG Monitoring SystemEpitelK242930Natus BrainWatch SystemNatus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)K232779QUEX ED; QUEX SQx World, Ltd.K242306SignalNED System (Model RE)Forest Devices, 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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