Polysmith Sleep System
Polysomnography Sleep System Version 10
1manufacturer
2catalogue numbers in this listing
9510(k) clearances naming this product code
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 America, Inc., United States |
|---|---|
| FDA product code | OLV |
| Device type | Standard Polysomnograph With Electroencephalograph |
| Device class | Class 2 |
| Regulation | 21 CFR 882.1400 |
| Establishment | Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Record published | 2016-09-24 |
| Record revised | 2024-03-04 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| A/ONEBED-SCORE-9X | In distribution | |
| A/ONEBED-SCORE-10X | 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 |
| 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 |
Showing 12 of 89. All products under Standard Polysomnograph With Electroencephalograph
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K073491 | 2008-01-11 |
| K050833 | 2005-04-29 |
| K033475 | 2004-01-07 |
| K022121 | 2002-07-29 |
| K011204 | 2001-05-08 |
| K000338 | 2000-04-26 |
| K992742 | 1999-10-14 |
| K983072 | 1998-12-01 |
| K854665 | 1986-06-05 |
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.