DR400
DR400 holter recorder with NEMEL002/003 patches
4manufacturers in China registered for this device type
1catalogue number
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 | Northeast Monitoring, Inc., United States |
|---|---|
| FDA product code | MWJ |
| Device type | Electrocardiograph, Ambulatory (Without Analysis) |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2800 |
| Establishment | Manufacturer |
| 510(k) | K142424 |
| Record published | 2021-10-27 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Special storage condition: Allowed Storage Conditions: -20C to 60C up to 1 month, and -20C to 30C for long term |
| Sizes | Length 6.7 cm; width 3.8 cm; depth 1.2 cm; weight 35 g |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DR400 | Length 6.7 cm | In distribution |
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.