Remi
REMI Mobile (Remote EEG Monitoring Software) - Ambulatory Startup Module
3manufacturers in China registered for this device type
12catalogue numbers in this listing
3510(k) clearances naming this product code
Who Else Makes It
Concentrated in Guangdong (2), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
Record
| Listed by | Epitel, United States |
|---|---|
| FDA product code | OMC |
| Device type | Reduced- Montage Standard Electroencephalograph |
| Device class | Class 2 |
| Regulation | 21 CFR 882.1400 |
| Establishment | Manufacturer |
| 510(k) | K203827 |
| Record published | 2022-12-16 |
| Record revised | 2026-05-06 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Storage environment temperature 10 to 40 °C; Handling environment temperature 10 to 40 °C; Storage environment humidity 10 to 95 % RH; Handling environment humidity 10 to 95 % RH |
| Packaging | Single unit, carton of 4, shipper of 4, case of 4, pallet of 4 |
| Sizes | Width 1 to 10.3 in; length 1 in; depth 0.25 in; height 6 in |
| Distribution end date | 2024-12-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 2.3.0 | In distribution | |
| 2.x.x.x | In distribution | |
| E001-20047 | Length 1 in | In distribution |
| 2.x.x.x | In distribution | |
| 20110 | Length 1 in | In distribution |
| p4.x.x | In distribution | |
| 20109 | Length 1 in | In distribution |
| 2.3 | Withdrawn | |
| R001 | Withdrawn | |
| 1.x.x.x | Withdrawn | |
| R001-20053 | Width 10.3 in | Withdrawn |
| ab3.x.x | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| X-Series | Advanced Brain Monitoring, Inc. | 59 |
| Sleep Profiler PSG2 | Advanced Brain Monitoring, Inc. | 22 |
| Sleep Profiler | Advanced Brain Monitoring, Inc. | 13 |
| Natus | Xltek | 5 |
| Narcotrend Patient lead | MT Monitortechnik Gmbh & Co. KG | 2 |
| Reduced- Montage Standard Electroencephalograph | GE Healthcare Finland OY | 2 |
| Quex S | QX World KFT | 2 |
| AE-120A EEG Head Set | Nihon Kohden Corp. | 2 |
| VitalEEG Portable System | Nihon Kohden America, Inc. | 2 |
| Nurochek-Pro | Headsafe MFG PTY Ltd | 2 |
| Quex ED | QX World KFT | 2 |
| Global Reference Module 4 | Neuralynx, Inc. | 1 |
Showing 12 of 87. All products under Reduced- Montage Standard Electroencephalograph
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K243185 | 2025-03-21 |
| K230933 | 2023-06-30 |
| K203827 | 2021-03-29 |
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.