Standard Polysomnograph With Electroencephalograph
SpO2 probe Adults, child (from 15 to 50 kg) Finger, disposable
1manufacturer
17catalogue 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 | Nihon Kohden Corp., Japan |
|---|---|
| FDA product code | OLV |
| Device type | Standard Polysomnograph With Electroencephalograph |
| Device class | Class 2 |
| Regulation | 21 CFR 882.1400 |
| Establishment | Specification developer, Manufacturer |
| Record published | 2016-09-05 |
| Record revised | 2024-03-04 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, serial number |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| LS-901AJ | In distribution | ||
| JE-912AK | In distribution | ||
| KE-910A | In distribution | ||
| QP-150AK | In distribution | ||
| JW-125A | In distribution | ||
| JW-124A | In distribution | ||
| NE-311A | In distribution | ||
| TL-052S | Adult | 5 | In distribution |
| TL-062S | Child | 5 | In distribution |
| JE-922A | In distribution | ||
| JE-921A | In distribution | ||
| SB-120A | In distribution | ||
| JW-122A | In distribution | ||
| JE-208A | In distribution | ||
| YZ-0226 | In distribution | ||
| YC-120A | In distribution | ||
| KC-120A | 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 |
| Sleep Profiler PSG2 | Advanced Brain Monitoring, Inc. | 10 |
| Sleep Profiler | Advanced Brain Monitoring, Inc. | 8 |
| 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.