Sleep Profiler
Sleep Profiler is a wearable recording system for physiological signals during sleep in adult patients. SP40 and SP29 models record EEG, eye-movement, ECG or muscle-activity signals, with…
Sleep Profiler is a wearable recording system for physiological signals during sleep in adult patients. SP40 and SP29 models record EEG, eye-movement, ECG or muscle-activity signals, with optional motion, sound and photoplethysmographic measurements.
The battery-powered headset works with sensors on the head or body and software that transfers and stores study data. Records are saved in EDF format for analysis using compatible third-party applications.
Listed Item
Sleep Profiler LE Device Kit (Arm&Chin EMG) Italian
Model Differences
SP29 Sleep Profiler PSG2 adds nasal airflow, chest and abdominal respiratory effort, finger pulse rate and oxygen-saturation measurements. The prescription system may be used at home, in a healthcare facility or in clinical research.
Who Else Makes It
Concentrated in Guangdong (2), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
Record
| Listed by | Advanced Brain Monitoring, Inc., United States |
|---|---|
| FDA product code | OMC |
| Device type | Reduced- Montage Standard Electroencephalograph |
| Device class | Class 2 |
| Regulation | 21 CFR 882.1400 |
| Establishment | Manufacturer |
| 510(k) | K152040 |
| Record published | 2022-11-15 |
| Record revised | 2022-11-28 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | manufacturing date, serial number |
| Storage | Handling environment temperature 5 to 40 °C; Handling environment humidity 15 to 90 % RH; Handling environment atmospheric pressure 70 to 106 KiloPascal; Storage environment temperature -25 to 70 °C; Storage environment humidity 15 to 90 % RH; Storage environment atmospheric pressure 70 to 106 KiloPascal |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SP29-1014.LE | In distribution | |
| SP40-1001.LE(ITA) | In distribution | |
| SP29-1014.LE(POL) | In distribution | |
| SP40-1001.LE(DUT) | In distribution | |
| SP40-1001.LE(POL) | In distribution | |
| SP29-1014.LE(ITA) | In distribution | |
| SP40-1001.LE(GRE) | In distribution | |
| SP29-1015.LE | In distribution | |
| SP40-1001.LE(GER) | In distribution | |
| SP40-1001.LE(TUR) | In distribution | |
| SP40-1001.LE, SP29-1003.LE | In distribution | |
| SP40-1001.LE(SWISS) | In distribution | |
| SP40-1001.LE(FRE) | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| X-Series | Advanced Brain Monitoring, Inc. | 59 |
| Sleep Profiler PSG2 | Advanced Brain Monitoring, Inc. | 22 |
| Remi | Epitel | 12 |
| Natus | Xltek | 5 |
| Narcotrend Patient lead | MT Monitortechnik Gmbh & Co. KG | 2 |
| Reduced- Montage Standard Electroencephalograph | GE Healthcare Finland OY | 2 |
| Quex S | QX World KFT | 2 |
| AE-120A EEG Head Set | Nihon Kohden Corp. | 2 |
| VitalEEG Portable System | Nihon Kohden America, Inc. | 2 |
| Nurochek-Pro | Headsafe MFG PTY Ltd | 2 |
| Quex ED | QX World KFT | 2 |
| Global Reference Module 4 | Neuralynx, Inc. | 1 |
Showing 12 of 87. All products under Reduced- Montage Standard Electroencephalograph
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K152040 | 2015-10-30 |
| K130013 | 2013-01-31 |
| K120447 | 2012-06-20 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.