Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)
B105P ATO Model
6manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Guangdong (5), 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 |
| Edan Instruments, Inc. | Shenzhen | Guangdong | Contract manufacturer | 56 |
| Shenzhen Comen Medical Instruments Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 24 |
| Guangdong Biolight Meditech Co., Ltd. | Zhuhai | Guangdong | Manufacturer | 19 |
Record
| Listed by | GE Medical Systems Information Technologies, Inc., United States |
|---|---|
| FDA product code | CBR |
| Device type | Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) |
| Device class | Class 2 |
| Regulation | 21 CFR 868.1700 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K213490 |
| Record published | 2022-04-12 |
| Record revised | 2026-01-30 (version 2) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Label carries | manufacturing date, serial number |
| Storage | Handling environment humidity 15 to 90 % RH; Handling environment atmospheric pressure 70 to 106 KiloPascal; Storage environment atmospheric pressure 70 to 106 KiloPascal; Storage environment temperature -20 to 60 °C; Storage environment humidity 10 to 90 % RH; Handling environment temperature 5 to 35 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| B105P VSP3.0 Patient Monitor | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) | GE Healthcare Finland OY | 4 |
| Trulink | Spacelabs Healthcare (Washington), Inc | 3 |
| Spacelabs Healthcare | Spacelabs Healthcare (Washington), Inc | 1 |
| 19″display(adapter/2.3M | Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | 1 |
| 22″display(adapter/2.3M | Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | 1 |
| UltraviewSL | Spacelabs Healthcare (Washington), Inc | 1 |
| AG Module(O2/package/accessory) | Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | 1 |
| 19″display(adapter/10M/VP1) | Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | 1 |
| Spacelabs | Spacelabs Healthcare (Washington), Inc | 1 |
| Carescape B850 | GE Healthcare Finland OY | 1 |
| SMR integrated mount accessory Kit | Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | 1 |
Recalls Naming This Product
6 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| GE Healthcare Finland OY | 510(k) number | 2025-09-26 | Class II | Component change control | Potential loss of monitoring on affected monitors when powered by certain batteries. Affected batteries can lose capability to hold charge and provide back up power. If this situation occurs, it will cause loss of patient monitoring and pot | 7408 |
| GE Medical Systems, LLC | 510(k) number | 2022-11-16 | Class II | Device Design | GE Healthcare has become aware that if certain B1x5P / B1x5M patient monitors use “mmHg” or “kPa” as the unit for CO2 measurement, the displayed value for CO2 measurement can be inaccurate when used in a location that is not at or near sea | 826 devices |
| GE Medical Systems, LLC | 510(k) number | 2022-11-16 | Class II | Device Design | GE Healthcare has become aware that if certain B1x5P / B1x5M patient monitors use “mmHg” or “kPa” as the unit for CO2 measurement, the displayed value for CO2 measurement can be inaccurate when used in a location that is not at or near sea | 388 units |
| GE Medical Systems, LLC | 510(k) number | 2022-11-16 | Class II | Device Design | GE Healthcare has become aware that if certain B1x5P / B1x5M patient monitors use “mmHg” or “kPa” as the unit for CO2 measurement, the displayed value for CO2 measurement can be inaccurate when used in a location that is not at or near sea | 3905 units |
| GE Medical Systems, LLC | 510(k) number | 2022-11-16 | Class II | Device Design | GE Healthcare has become aware that if certain B1x5P / B1x5M patient monitors use “mmHg” or “kPa” as the unit for CO2 measurement, the displayed value for CO2 measurement can be inaccurate when used in a location that is not at or near sea | 5962 |
| GE Medical Systems, LLC | 510(k) number | 2022-11-16 | Class II | Device Design | GE Healthcare has become aware that if certain B1x5P / B1x5M patient monitors use “mmHg” or “kPa” as the unit for CO2 measurement, the displayed value for CO2 measurement can be inaccurate when used in a location that is not at or near sea | 3348 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.