Monitor, St Segment With Alarm
PRE-Configured EEG Lead SET 2 General, 898051
7manufacturers in China registered for this device type
2catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (5), Jiangsu (1), Hebei (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 |
| Contec Medical Systems Co., Ltd. | Qinhuangdao | Hebei | Manufacturer | 22 |
| Guangdong Biolight Meditech Co., Ltd. | Zhuhai | Guangdong | Manufacturer | 19 |
Record
| Listed by | GE Healthcare Finland OY, Finland |
|---|---|
| FDA product code | MLD |
| Device type | Monitor, St Segment With Alarm |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1025 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K051883 |
| Record published | 2016-06-16 |
| Record revised | 2025-08-25 (version 4) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
| Storage | Storage environment temperature -25 to 70 °C; Storage environment humidity 10 to 90 % RH; Handling environment atmospheric pressure 66 to 106 KiloPascal; Storage environment atmospheric pressure 50 to 106 KiloPascal; Handling environment humidity 10 to 90 % RH; Handling environment temperature 10 to 40 °C |
| Distribution end date | 2025-07-11 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| E-EEG-00 | In distribution | |
| Pre-conf. EEG Lead Set 2 General, 898051 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Welch Allyn, Inc. | Welch Allyn, Inc. | 48 |
| Vital Signs | Carefusion Finland 320 Oy | 23 |
| Lifee | CAF Medical Solutions Inc | 7 |
| Spacelabs Healthcare | Spacelabs Healthcare (Washington), Inc | 7 |
| Athena GTX Device Management Suite (Adms) Software | Athena GTX | 2 |
| Xhibit Telemetry Receiver | Spacelabs Healthcare (Washington), Inc | 1 |
| Contec | Contec Medical Systems Co., Ltd. | 1 |
| Advanced Patient Monitor | Advanced Instrumentations, Inc. | 1 |
| Xhibit | Spacelabs Healthcare (Washington), Inc | 1 |
| Comen | Shenzhen Comen Medical Instruments Co., Ltd. | 1 |
| Patient Monitor | Edan Instruments, Inc. | 1 |
| XTR | Spacelabs Healthcare (Washington), Inc | 1 |
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.