DeepRESP— 510(k) K252330

Substantially Equivalent

Nox Medical Ehf

FDA 510(k) clearance K252330 for DeepRESP, Substantially Equivalent on 2025-11-17. Applicant: Nox Medical Ehf. Device class: 2.

Clearance details

Applicant: Nox Medical Ehf
Product code: Code OLZ
Device class: Class 2
Regulation: 21 CFR 882.1400
Advisory panel: Neurology
Date received: 2025-07-25
Decision date: 2025-11-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Reykjavik, IS

Download summary PDF View on FDA.gov ↗

Recent devices under product code OLZ

K253390 — SOMNUM (SOMNUM)2026-06-27
K253668 — Onera SleepMap (SLEEPMAP)2026-03-08
K250851 — Hypnos (369054-200)2025-12-14
K250058 — NEAT 0012025-04-10
K241960 — DeepRESP2025-03-14

More clearances from Nox Medical Ehf

K260585 — Noxturnal Web2026-03-20
K241288 — Noxturnal Web2024-12-23
K151361 — Nox RIP Belts & Cables2015-11-06

Data sourced from openFDA. This site is unofficial and independent of the FDA.