Sleep Profiler
Sleep Profiler Device Kit Turkish (No sensors)
1manufacturer
8catalogue numbers in this listing
Who Else Makes It
Registered in Jiangsu. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jiangyin Sinbon Electronics Co Ltd | Jiangyin | Jiangsu | Contract manufacturer | 13 |
Record
| Listed by | Advanced Brain Monitoring, Inc., United States |
|---|---|
| FDA product code | OLV |
| Device type | Standard Polysomnograph With Electroencephalograph |
| Device class | Class 2 |
| Regulation | 21 CFR 882.1400 |
| Establishment | Manufacturer |
| 510(k) | K152040 |
| Record published | 2016-09-23 |
| Record revised | 2023-06-20 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Storage environment atmospheric pressure 70 to 106 KiloPascal; Storage environment humidity 15 to 93 % RH; Storage environment temperature -25 to 70 °C; Handling environment atmospheric pressure 70 to 106 KiloPascal; Handling environment humidity 15 to 93 % RH; Handling environment temperature 5 to 40 °C |
| Packaging | Kit of 10 sp strips of 10, kit of 50 headbands of 50, kit of 25 headbands of 25 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SP40-1001, SP29-1003 | In distribution | |
| SP40-4225.1 | In distribution | |
| SP40-1001 | In distribution | |
| SP40-1003 | In distribution | |
| SP40-1001(TUR) | In distribution | |
| SP40-4305 | In distribution | |
| SP40-4101 | In distribution | |
| SP29-4306 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Alice 6 | Respironics Inc. | 58 |
| Somnostar | Carefusion | 28 |
| Standard Polysomnograph With Electroencephalograph | Nihon Kohden America, Inc. | 18 |
| Standard Polysomnograph With Electroencephalograph | Nihon Kohden Corp. | 17 |
| Sleep Profiler PSG2 | Advanced Brain Monitoring, Inc. | 10 |
| Trackit Sleepwalker | Lifelines Ltd. | 8 |
| micromed | Micromed, Inc. | 7 |
| Compumedics Grael | Compumedics Limited | 6 |
| Neurovirtual | Neurovirtual USA, Inc. | 4 |
| Pro-Flow | Respironics Inc. | 3 |
| Serenity TH01 Thermocouple Sensor w/ Hanger, 1.5mm DIN, 2.0m | Neurotronics, LLC | 3 |
| Xltek | Embla Systems | 3 |
Showing 12 of 89. All products under Standard Polysomnograph With Electroencephalograph
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.