X-Series
The X-Small 10-20 Single-Use Strip Kit is a disposable placement accessory for compatible B-Alert EEG sensors. The filed package contains two strips and no sensors, so it supplies the strip…
The X-Small 10-20 Single-Use Strip Kit is a disposable placement accessory for compatible B-Alert EEG sensors. The filed package contains two strips and no sensors, so it supplies the strip interface rather than the signal-capturing sensors.
Its 10-20 designation refers to the standardized scalp-location system used to position EEG electrodes. Standardized locations make recordings more consistently described and compared; they do not turn the strip kit into an EEG acquisition device.
Listed Item
X-Small 10-20 Single-Use Strip Kit (Qty 2 No Sensors)
Strip and Sensor Relationship
Advanced Brain Monitoring distinguishes single-use sensor strips from sensor kits in its B-Alert materials. The strip provides the electrode-position interface for the compatible headset; sensors and acquisition hardware belong to the wider recording system and are not included in this two-strip package.
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 | Advanced Brain Monitoring, Inc., 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) | K131383 |
| Record published | 2022-06-28 |
| Record revised | 2024-06-06 (version 6) |
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 7 to 20 °C; Storage environment humidity 15 to 95 % RH; Storage environment atmospheric pressure 70 to 106 KiloPascal; Handling environment temperature 7 to 20 °C; Handling environment humidity 15 to 95 % RH; Handling environment atmospheric pressure 70 to 106 KiloPascal |
| Packaging | Pack of 5, kit of 5 headbands of 5 |
| Distribution end date | 2018-04-12 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 30-4210 | In distribution | |
| XS30-4252.10 | In distribution | |
| 02-4301 | In distribution | |
| XS24-1002 | In distribution | |
| XS30-4205 | In distribution | |
| XS30-4204 | In distribution | |
| XS30-4201 | In distribution | |
| XS30-4222 | In distribution | |
| XS24-4200 | In distribution | |
| XS30-4202 | In distribution | |
| XS10-4220 | In distribution | |
| XS30-4210.2 | In distribution | |
| XS30-4250.5 | In distribution | |
| 02-4101 | In distribution | |
| XS30-1001, XS30-1003 | In distribution | |
| UN03-4006 | In distribution | |
| XS30-4212 | In distribution | |
| XS10-1001, XS10-1003 | In distribution | |
| XS30-4251 | In distribution | |
| 03-5105 | In distribution | |
| XS30-4207 | In distribution | |
| XS10-4221 | In distribution | |
| XS30-4250 | In distribution | |
| XS30-4251.10 | In distribution | |
| XS30-4001 | In distribution | |
| XS30-4211.5 | In distribution | |
| XS30-1004, XS30-1005 | In distribution | |
| ES31-1001, ES31-1003 | In distribution | |
| XS30-4211 | In distribution | |
| 02-4102 | In distribution | |
| XS30-4206 | In distribution | |
| XS24-1003 | In distribution | |
| XS30-4302 | In distribution | |
| XS30-4212.5 | In distribution | |
| XS30-4252 | In distribution | |
| 02-4103 | In distribution | |
| 02-4321 | In distribution | |
| XS24-4201 | In distribution | |
| 30-4211 | In distribution | |
| XS30-4212 | In distribution | |
| XS30-4200 | In distribution | |
| 30-4212 | In distribution | |
| 02-4105 | In distribution | |
| XS02-4351 | In distribution | |
| XS30-4301 | In distribution | |
| XS24-4001 | In distribution | |
| XS24-4202 | In distribution | |
| XS10-4001 | In distribution | |
| 02-4321 | In distribution | |
| XS30-4210 | In distribution | |
| XS30-1001 | In distribution | |
| XS10-4222 | In distribution | |
| XS30-4211 | In distribution | |
| XS30-4220 | In distribution | |
| XS24-1001 | In distribution | |
| XS30-4221 | In distribution | |
| UN03-4009 | In distribution | |
| XS10-4321 | Withdrawn | |
| XS24-4321 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Sleep Profiler PSG2 | Advanced Brain Monitoring, Inc. | 22 |
| Sleep Profiler | Advanced Brain Monitoring, Inc. | 13 |
| Remi | Epitel | 12 |
| 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 |
|---|---|
| K152040 | 2015-10-30 |
| K130013 | 2013-01-31 |
| K120447 | 2012-06-20 |
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.