DR300
DR300 holter recorder w/ 5L patient cable
4manufacturers in China registered for this device type
2catalogue 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 | 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 -40C to 70C |
| Sizes | Length 8.6 cm; width 6 cm; depth 2 cm; weight 70.9 g |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DR300 7L | Length 8.6 cm | In distribution |
| DR300 5L | Length 8.6 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.