X8 System (Sleep Profiler, Sleep Profiler PSG2)

• EUDAMED Basic UDI-DI 0851113007SP29SPPYC registered 23 May 2025 Active
• FDA 510(k) K152040 decided 30 Oct 2015 Active· +2 more in the status table
• FDA GUDID UDI-DI 00851113007239 listed 24 Sep 2016 Listed

1. 20 Jun 2012 Cleared FDA 510(k) K120447
2. 31 Jan 2013 Cleared FDA 510(k) K130013
3. 30 Oct 2015 Cleared FDA 510(k) K152040
4. 24 Sep 2016 Listed FDA GUDID 00851113007239
5. 23 May 2025 Registered EUDAMED 0851113007SP29SPPYC

Trade name

X8 System (Sleep Profiler, Sleep Profiler PSG2) EUDAMED

Sleep Profiler GUDID

Generic name

Electroencephalograph

Device name

X8 System

Model / reference

SP40-4305

Primary DI / UDI-DI

00851113007239

Basic UDI-DI

0851113007SP29SPPYC

510(k) Number

K120447 ↗

K130013 ↗

K152040 ↗

FDA product code

OLV, OMC

EMDN code

N01010203 EEG headsets

GMDN term

Electroencephalograph

Device class

Class IIb EUDAMED

Class II GUDID

Regulation number

882.1400

System or procedure pack

System

EU registration type

System or procedure pack

Medical purpose

The X8 System is intended for prescription use in the home, healthcare facility, or clinical research environment to acquire, record, transmit, and display physiological signals from adult patients. All X8 models (SP40, SP29, and XS29) acquire, record, transmit, and/or display electroencephalogram (EEG), electrooculogram (EOG), electrocardiogram (ECG), and/or electromyogram (EMG) signals, with optional accelerometer, acoustical, and photoplethysmographic signals. Model SP29 additionally includes a nasal pressure transducer and cannula (for airflow), thoracic and abdomen respiratory effort, and pulse rate and oxyhemoglobin saturation from the finger. The X8 system only acquires and displays physiological signals; no claims are being made for analysis of the acquired signals with respect to the accuracy, precision, and reliability.

GUDID distribution status

In Commercial Distribution

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

EUDAMED SRN

US-PR-000044717

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• Sleep Profiler PSG2 SP29-1017.LE

  Class II

  CE/MDR FDA 510(k) K152040 Active Cleared 30 Oct 2015 +1authorizations

• Sleep Profiler SP29-1020.LE

  Class II

  CE/MDR FDA 510(k) K152040 Active Cleared 30 Oct 2015 +1authorizations

• Sleep Profiler SP29-1020.LE(ITA)

  Class II

  CE/MDR FDA 510(k) K152040 Active Cleared 30 Oct 2015 +1authorizations

• Sleep Profiler SP29-1025.LE

  Class II

  CE/MDR FDA 510(k) K152040 Active Cleared 30 Oct 2015 +1authorizations

See all devices from Advanced Brain Monitoring, Inc. →