FDA.reportPublic FDA data

DeepRESP

Primary DI
15694311112099
Brand
DeepRESP
Company
Nox Medical ehf.
Model
DEEPRESP
Published
2025-06-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
OLZAutomatic Event Detection Software For Polysomnograph With Electroencephalograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OLZAutomatic Event Detection Software For Polysomnograph With ElectroencephalographNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K241960000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K241960000DeepRESPNox Medical Ehf2025-03-14OLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15694311112099PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1569431111209915694311112099

GMDN Terms#

Term, Definition table
TermDefinition
Sleep disorder interpretive software, professional-onlyAn interpretive software program intended to be used exclusively by healthcare professionals to collect and analyse patient physiological data during sleep and publish reports to assist diagnosis of sleep disorders (e.g., insomnia, sleep apnoea). It is typically used as part of a polysomnography study using a wide range of data of [e.g., electrocardiogram (ECG), electroencephalogram (EEG), haemoglobin oxygen saturation (SpO2), chest wall motion, airflow, eye movement].

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
365741462
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
15694311111887Nox Nasal Pressure Cannula with FilterNOX-MDR_CANAF405520112026-01-28
15694311111894Nox Nasal Pressure Cannula with FilterNOX-MDR_CANAF405520112026-01-28
15694311112112SomrystSOMRYST6510102024-12-30
15694311111672Nox SAS Body Cable - RightESNAP4SASRMPAC1US5622162025-06-06
15694311111689Nox SAS Body Cable - LeftESNAP4SASLMPAC1US5622172025-06-06
15694311111719Nox SAS Head CableESNAP10SASLMPAC1US5622182025-06-06
15694311111191Nox SAS Body Cable - RightESNAP4SASRMPAC1US5622162025-06-06
15694311111207Nox SAS Body Cable - LeftESNAP4SASLMPAC1US5622172025-06-06
15694311111214Nox SAS Head CableESNAP10SASLMPAC1US5622182025-06-06
15694311112075Noxturnal WebNOXTURNAL_WEB2025-06-05
15694311110477Nox Mini USB CableNOX-USBCPAC15620112016-09-16
15694311110736QDC-PRO KitNOX-QDCPETL_KIT15140112016-09-16
15694311110354Nox Snap-on Lead, 100 cmNOX-ESNAP11PAC25540282016-09-16
15694311110361Nox Snap-on Double Lead, 50/100 cmNOX-ESNAP1PAC15543102016-09-16
15694311110378Nox Snap-on Double Lead, 30/50 cmNOX-PESNAP1PAC15543112016-09-16
15694311110279Nox Snap-on Lead, 50 cmNOX-ESNAP7PAC25540202016-09-16
15694311110286Nox Snap-on Lead, 30 cmNOX-PESNAP7PAC25540212016-09-16
15694311110316Nox Snap-on Lead, 150 cmNOX-ESNAP9PAC25540242016-09-16
15694311110323Nox Snap-on Lead, 100 cmNOX-PESNAP9PAC25540252016-09-16
15694311110330Nox Snap-on Lead, 150 cmNOX-ESNAP10PAC25540262016-09-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860008953117NEATBrain Electrophysiology Laboratory Company, LLCOLZ2026-05-12
00850049266055WavebandBeacon Biosignals, Inc.OLZ2026-04-17
00850049266062WavebandBeacon Biosignals, Inc.OLZ2026-04-17
B566847020ZmachineGeneral SleepOLZ2026-04-16
00606959055735Sleepware G3 Respironics, Inc.OLZ2026-01-22
00817111021332PolysmithNeurotronics, LLCOLZ2025-09-23
00864458000476EnsoSleepEnsodata, Inc.OLZ2025-04-14
00817111021264Live View Panel Pro Version 2.0Neurotronics, LLCOLZ2024-05-09
00864458000414EnsoSleepEnsodata, Inc.OLZ2024-02-23
00850015266706Sleep ProfilerADVANCED BRAIN MONITORING, INC.OLZ2023-10-23
00817111021257Polysmith Version 12.2Neurotronics, LLCOLZ2022-12-28
B600700014Cerebra Sleep SystemCerebra Medical LtdOLZ2022-07-13
15694311111665Noxturnal US APPNox Medical ehf.OLZ2021-10-18
15694311111610Nox A1® EEG 5 Lead Gold Electrode CableNox Medical ehf.OLZ2021-09-07
15694311111627Nox A1® EEG Head Cable Nox Medical ehf.OLZ2021-09-07
15694311111566Nox A1s RecorderNox Medical ehf.OLZ2021-07-10
15694311111580Nox A1s SystemNox Medical ehf.OLZ2021-07-10
15694311111597Nox C1s KitNox Medical ehf.OLZ2021-07-10
15694311110682Nox A1 Starter Sensor Kit, AdultNox Medical ehf.OLZ2021-02-03
15694311110699Nox A1 Starter Sensor Kit, PediatricNox Medical ehf.OLZ2021-02-03
15694311111498Nox C1 Access PointNox Medical ehf.OLZ2021-02-03
15694311111504Nox C1 KitNox Medical ehf.OLZ2021-02-03
00627987257502Esprit NovaSignalitica IncOLZ2020-12-06
15694311110095Nox A1 Carry CaseNox Medical ehf.OLZ2020-04-27
15694311110453Nox A1 EEG 5 Lead Gold Electrode CableNox Medical ehf.OLZ2020-04-27
15694311110521Nox A1 EEG Head CableNox Medical ehf.OLZ2020-04-27
00817111021172Polysmith Version 12.0Neurotronics, LLCOLZ2020-04-01
15694311110019Noxturnal APPNox Medical ehf.OLZ2020-02-24
15694311110590Nox C1 Access PointNox Medical ehf.OLZ2020-02-24
15694311110903Nox A1 RecorderNox Medical ehf.OLZ2020-02-24