Fukuda Denshi
13 catalogue numbers from OP-119TE 63/30M, listed by Fukuda Denshi Co., Ltd., Japan, under Recorder, Paper Chart. 9 manufacturers in China are registered for this product code.
9manufacturers in China registered for this device type
13catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (3), Shanghai (2), Jiangsu (2). 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 |
| Shanghai Jolly Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 99 |
| Shanghai Lions Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 82 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
| Edan Instruments, Inc. | Shenzhen | Guangdong | Contract manufacturer | 56 |
| Orantech Inc. | Shenzhen | Guangdong | Contract manufacturer | 40 |
| Little Doctor Electronic(Nantong) Co., Ltd. | Nantong | Jiangsu | Contract manufacturer | 17 |
| Xiamen MK Health Care Product Co., Ltd. | Xiamen | Fujian | Manufacturer | 7 |
| Tianjin Grand Paper Industry Co., Ltd. | Tianjin | Tianjin | Manufacturer | 2 |
Record
| Listed by | Fukuda Denshi Co., Ltd., Japan |
|---|---|
| FDA product code | DSF |
| Device type | Recorder, Paper Chart |
| Device class | Class 1 |
| Regulation | 21 CFR 870.2810 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K971440 |
| Record published | 2022-12-27 |
| Record revised | 2022-12-28 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, manufacturing date |
| Distribution end date | 2022-12-26 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| OP-119TE 63/30M | In distribution | |
| OP-358TE 145/30 | In distribution | |
| OP-222TE | In distribution | |
| OP-124TE 50/20M | In distribution | |
| OP050-02TDR | In distribution | |
| OP-618TE | In distribution | |
| OP-115TE 50/30M | In distribution | |
| OP-18TE 50/30M | In distribution | |
| OP-122TE 63/20M | In distribution | |
| OP-69TE 210/30M | In distribution | |
| OP-621TE | In distribution | |
| OP-382TE | In distribution | |
| OP-119TE 63/30M | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Vermed | Graphic Controls Acquisition Corporation | 153 |
| Cardinal Health | Cardinal Health 200, LLC | 91 |
| Kendall | Cardinal Health | 54 |
| Henry Schein | Henry Schein, Inc. | 31 |
| non branded | Cardinal Health | 28 |
| ECG Recording Paper | Diagramma AG | 16 |
| Welch Allyn, Inc. | Welch Allyn, Inc. | 16 |
| MediChoice | Owens & Minor Distribution, Inc. | 15 |
| GE Healthcare | Graphic Controls Acquisition Corporation | 12 |
| Paper | Philips Medical Systems Hsg | 12 |
| Curaplex | Bound Tree Medical, LLC | 5 |
| Vital Signs™ | AirLife Finland Oy | 5 |
Showing 12 of 851. All products under Recorder, Paper Chart
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.