FDA 510(k)

DeepRESP

K-Number: K252330 · 2025-11-17

Decision Date2025-11-17

Product CodeOLZ

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

DeepRESP is the device name listed in this FDA 510(k) record. The listed applicant is Nox Medical Ehf. It received FDA 510(k) clearance on 2025-11-17 under 510(k) number K252330. The device is classified under product code OLZ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DeepRESP?

DeepRESP is a medical device that received FDA 510(k) clearance on 2025-11-17. The listed applicant is Nox Medical Ehf. The 510(k) number is K252330.

When did DeepRESP receive FDA 510(k) clearance?

DeepRESP received FDA 510(k) clearance on 2025-11-17, under 510(k) number K252330.

Who is the listed applicant for DeepRESP?

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

What is the FDA product code for DeepRESP?

The FDA product code for DeepRESP is OLZ.

Other records listing Nox Medical Ehf 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.

K260585Noxturnal Web K241960DeepRESP K241288Noxturnal Web

Related Devices (Code: OLZ)

K253390SOMNUM (SOMNUM)Honeynaps Co., Ltd.K253668Onera SleepMap (SLEEPMAP)Onera B.V.K250851Hypnos (369054-200)Cadwell Industries, Inc.K250058NEAT 001Brain Electrophysiology Laboratory Company, LLC K241960DeepRESPNox Medical Ehf K242094Dreem 3SBeacon Biosignals, 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.