Micromed
The Micromed BRAIN QUICK system is an integrated acquisition system for physiological signals such as EEG and/or polysomnography (PSG) . The system includes hardware recorders, intended to…
The Micromed BRAIN QUICK system is an integrated acquisition system for physiological signals such as EEG and/or polysomnography (PSG). The system includes hardware recorders, intended to acquire and temporarily store physiological signals for EEG and/or PSG, and software which is used for the signal acquisition, display, storage, process and measure of biologic signals.
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 | Micromed, Inc., United States |
|---|---|
| FDA product code | OLV |
| Device type | Standard Polysomnograph With Electroencephalograph |
| Device class | Class 2 |
| Regulation | 21 CFR 882.1400 |
| 510(k) | K071782 |
| Record published | 2018-03-21 |
| Record revised | 2022-11-28 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| BRAIN SPY PLUS | In distribution | |
| SD LTM 32 PLUS | In distribution | |
| BRAIN QUICK | In distribution | |
| SD LTM 32 EXPRESS | In distribution | |
| MORPHEUS | In distribution | |
| SD LTM 64 EXPRESS | In distribution | |
| SD LTM 64 PLUS | 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 |
| 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
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Micromed S.P.A. | 510(k) number | 2026-05-04 | Class II | Software Design Change | Natus has become aware of two complaints related to the SD LTM 64 PLUS where the EEG traces acquired from two or four different amplifiers used in a multiple amplifier configuration (128 or 256 channels) running firmware version 2022.02 wer | 207 units |
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.