Contec
Catalogue number CMS7000, listed by Contec Medical Systems Co., Ltd., China, under Monitor, St Segment With Alarm. 7 manufacturers in China are registered for this product code.
7manufacturers in China registered for this device type
1catalogue number
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 | Contec Medical Systems Co., Ltd., China |
|---|---|
| FDA product code | MLD |
| Device type | Monitor, St Segment With Alarm |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1025 |
| Establishment | Manufacturer |
| 510(k) | K101692 |
| Record published | 2016-09-24 |
| Record revised | 2021-11-10 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CMS7000 | In distribution |
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 |
| Monitor, St Segment With Alarm | GE Healthcare Finland OY | 2 |
| Xhibit Telemetry Receiver | Spacelabs Healthcare (Washington), Inc | 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 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Contec Medical Systems Co., Ltd. | 510(k) number | 2025-04-10 | Class II | Software design | Patient monitor has nine identified cybersecurity vulnerabilities. | 7773 |
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.