Alice 6
Alice 6 LDx is a Philips Respironics polysomnography system used to record physiological signals during a sleep study. The LDx base station works with an LDxS or LDxN headbox, offering 19…
Alice 6 LDx is a Philips Respironics polysomnography system used to record physiological signals during a sleep study. The LDx base station works with an LDxS or LDxN headbox, offering 19 or 32 EEG inputs respectively.
The filed item describes an Alice 5-to-6 conversion kit for U.S. and North American systems. It is a system conversion accessory, not a standalone sleep recorder.
Listed Item
Alice 6 LDx polysomnography system, (Alice 5 to 6 conversion/changeover kit), U.S./North America
System Conversion
The Alice 6 LDx configuration combines a base station with a selected headbox, respiratory inductance plethysmography, a differential pressure transducer and Sleepware diagnostic software.
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 | Respironics Inc., United States |
|---|---|
| FDA product code | OLV |
| Device type | Standard Polysomnograph With Electroencephalograph |
| Device class | Class 2 |
| Regulation | 21 CFR 882.1400 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2016-09-18 |
| Record revised | 2024-10-14 (version 6) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Storage environment temperature -20 to 60 °C; Storage environment humidity 15 to 95 % RH; Storage environment temperature -4 to 140 °F |
| Distribution end date | 2021-03-05 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| LDE | In distribution | |
| Alice 6 LDE Base Station, INTL | In distribution | |
| LDXN | In distribution | |
| Alice 6 Conversion, LDE, INTL | In distribution | |
| Alice 6 ConversionUpgrade, LDx, INTL | In distribution | |
| ALICE 6 | In distribution | |
| Alice 6 Base Station, LDx with Masimo, NA | In distribution | |
| Alice 6 Pressure Sensor, INTL | In distribution | |
| Alice 6 Base Station, LDE with Masimo, INTL | In distribution | |
| Alice 6 LDxS Headbox, INTL and Brazil | In distribution | |
| LDXN | In distribution | |
| Alice 6 LDxS Headbox, INTL | In distribution | |
| ALICE 6 | In distribution | |
| Alice 6 Base Station, LDx with Masimo, INTL | In distribution | |
| Alice 6 Upgrade, LDE, US | In distribution | |
| LDXS | In distribution | |
| Alice 6 Base Station, LDE, INTL | In distribution | |
| Alice 6 Base Station, LDE with Masimo, NA | In distribution | |
| Alice 6 LDxN Headbox, NA | In distribution | |
| Alice 6, Base Station, LDE, INTL | In distribution | |
| Alice 6, Base Station, LDE, Brazil | In distribution | |
| ALICE 6 | In distribution | |
| Alice 6, Base Station System, LDx, Brazil | In distribution | |
| Alice 6 Therapy Circuit Interface Kit | In distribution | |
| ALICE 6 | In distribution | |
| Alice 6, Base Station, LDE, NA | In distribution | |
| Alice 6 LDx Base Station, NA (blue) | In distribution | |
| Alice 6 LDE Headbox, NA | In distribution | |
| Alice 6, Base Station, LDx, INTL | In distribution | |
| Alice 6 LDxN Headbox, INTL and Brazil | In distribution | |
| Alice 6, Accessory Sensor Kit, Infant, INTL | In distribution | |
| Alice 6 LDx Base Station, INTL (blue) | In distribution | |
| Alice 6 Upgrade, LDx, US | In distribution | |
| Alice 6 LDE Headbox, INTL and Brazil | In distribution | |
| Alice 6 LDxS Headbox, NA | In distribution | |
| Alice 6 Pressure Sensor, US | In distribution | |
| Alice 6 Base Station, LDx, INTL | In distribution | |
| LDXS | In distribution | |
| Alice 6, Base Station, LDx, NA | In distribution | |
| Alice 6 LDE Base Station, NA | In distribution | |
| LDE | In distribution | |
| Alice 6, Accessory Sensor Kit, Adult, INTL | In distribution | |
| Alice 6 LDE Headbox, INTL | In distribution | |
| ALICE 6 | In distribution | |
| Alice 6 Base Station, LDE, Japan | Withdrawn | |
| Alice 6 Base Station, LDx, Japan | Withdrawn | |
| Alice 6 LDE Headbox, Brazil | Withdrawn | |
| Alice 6 LDxS Headbox, Brazil | Withdrawn | |
| Alice 6, Base Station, LDx, China | Withdrawn | |
| Alice 6 LDE Headbox, China | Withdrawn | |
| Alice 6 Base Station, LDE, JP | Withdrawn | |
| Alice 6 LDxN Headbox, China | Withdrawn | |
| Alice 6 Base Station, LDx, JP | Withdrawn | |
| Alice 6 Base Station, LDE, China | Withdrawn | |
| Alice 6 Base Station, LDx, Brazil | Withdrawn | |
| Alice 6 Base Station, LDE, Brazil | Withdrawn | |
| Alice 6 LDxS Headbox, China | Withdrawn | |
| Alice 6 LDxN Headbox, Brazil | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| 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.