Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
B155M ATO Model
9manufacturers in China registered for this device type
1catalogue number
6510(k) clearances naming this product code
Who Else Makes It
Concentrated in Guangdong (7), Jiangsu (1), Hebei (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
| EMI (Dongguan) Asia Limited | Dongguan | Guangdong | Contract manufacturer | 9 |
| 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 |
| Orantech Inc. | Shenzhen | Guangdong | Contract manufacturer | 40 |
| Shenzhen Comen Medical Instruments Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 24 |
| Contec Medical Systems Co., Ltd. | Qinhuangdao | Hebei | Manufacturer | 22 |
| Guangdong Biolight Meditech Co., Ltd. | Zhuhai | Guangdong | Manufacturer | 19 |
Record
| Listed by | GE Medical Systems Information Technologies, Inc., United States |
|---|---|
| FDA product code | DRT |
| Device type | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2300 |
| 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 atmospheric pressure 70 to 106 KiloPascal; Storage environment temperature -20 to 60 °C; Handling environment humidity 15 to 90 % RH; Handling environment temperature 5 to 35 °C; Storage environment atmospheric pressure 70 to 106 KiloPascal; Storage environment humidity 10 to 90 % RH |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| B155 VSP3.0 Patient Monitor | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Model 7600 | IVY Biomedical Systems, Inc. | 82 |
| Model 7800 | IVY Biomedical Systems, Inc. | 66 |
| ECG | Zoll Medical Corporation | 30 |
| Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | Nihon Kohden America, Inc. | 18 |
| Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | Nihon Kohden Corp. | 12 |
| Model 7600EP | IVY Biomedical Systems, Inc. | 11 |
| Propaq M | Zoll Medical Corporation | 11 |
| Model 7700 | IVY Biomedical Systems, Inc. | 11 |
| CTM-300 | IVY Biomedical Systems, Inc. | 6 |
| Cable | Zoll Medical Corporation | 5 |
| Upmm | IVY Biomedical Systems, Inc. | 4 |
| ViSi | Sotera Wireless | 4 |
Showing 12 of 43. All products under Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K060307 | 2006-08-04 |
| K910665 | 1991-12-31 |
| K833552 | 1984-01-27 |
| K823904 | 1983-05-25 |
| K820416 | 1982-03-04 |
| K820417 | 1982-03-04 |
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.