EVO
EVO Docking Station USB Conn & EU PWR CBL
4manufacturers in China registered for this device type
4catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (2), Shanghai (1), Beijing (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 |
| Edan Instruments, Inc. | Shenzhen | Guangdong | Contract manufacturer | 56 |
| Philips (China) Investment Co., Ltd. Philips Healthcare – Shanghai CDC | Shanghai | Shanghai | Specification developer | 6 |
| DM Systems (Beijing) Co., Ltd. | Beijing | Beijing | Manufacturer | 1 |
Record
| Listed by | Spacelabs Healthcare (Washington), Inc |
|---|---|
| FDA product code | MWJ |
| Device type | Electrocardiograph, Ambulatory (Without Analysis) |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2800 |
| Record published | 2018-08-20 |
| Record revised | 2025-03-18 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Storage environment temperature -20 to 65 °C; Storage environment humidity 15 to 93 % RH; Storage environment atmospheric pressure 700 to 1060 millibar |
| Packaging | Case of 20 |
| Distribution end date | 2025-02-28 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Evo Recorder | In distribution | |
| EVO Docking Station | Withdrawn | |
| TAY | Withdrawn | |
| Evo Docking Station | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Spacelabs Healthcare | Spacelabs Healthcare (Washington), Inc | 60 |
| Welch Allyn, Inc. | Welch Allyn, Inc. | 58 |
| Norav NR Series | Norav Medical Inc. | 56 |
| Eclipse Pro | Spacelabs Healthcare (Washington), Inc | 25 |
| Seer 1000 | Getemed Medizin- UND Informationstechnik AG | 15 |
| Seer 1000 ECG Cable | Getemed Medizin- UND Informationstechnik AG | 12 |
| ECG Cable for Seer 1000 | Getemed Medizin- UND Informationstechnik AG | 12 |
| Seer | Suzuken Co., Ltd. | 12 |
| H12+ | Mortara Instrument, Inc. | 10 |
| Lifecard | Spacelabs Healthcare (Washington), Inc | 10 |
| H3+ Patient Cable | Mortara Instrument, Inc. | 10 |
| Spiderview | Microport CRM SRL | 9 |
Showing 12 of 107. All products under Electrocardiograph, Ambulatory (Without Analysis)
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.