Transmitters and Receivers, Physiological Signal, Radiofrequency
SpO2 probe, Child (from 15 to 50 kg) finger Infant (from 3 to 15 kg) toe, disposable
11manufacturers in China registered for this device type
22catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Guangdong (5), Jiangsu (2), Zhejiang (2). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
| Linxens Healthcare (Tianjin) Co., Ltd. | Jinnan District | Tianjin | Contract manufacturer | 7 |
| Dongguan CFE Electronic Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 2 |
| Chero Technology Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 1 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| Edan Instruments, Inc. | Shenzhen | Guangdong | Contract manufacturer | 56 |
| Orantech Inc. | Shenzhen | Guangdong | Contract manufacturer | 40 |
| Suzhou Prosteri Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 20 |
| Avita (Wujiang) Co., Ltd. | Wujiang | Jiangsu | Contract manufacturer | 15 |
| Hangzhou VivaLNK Medical Technology Co., Ltd. | Hangzhou | Zhejiang | Exporter | 4 |
Record
| Listed by | Nihon Kohden Corp., Japan |
|---|---|
| FDA product code | DRG |
| Device type | Transmitters And Receivers, Physiological Signal, Radiofrequency |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2910 |
| Establishment | Specification developer, Manufacturer |
| Record published | 2017-08-08 |
| Record revised | 2024-04-15 (version 7) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, serial number |
| Distribution end date | 2023-06-30 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| GZ-120P | In distribution | ||
| YP-814P | 20 | In distribution | |
| GZ-130P | In distribution | ||
| JL-030U1 | In distribution | ||
| YP-841T | 20 | In distribution | |
| TL-061S | 5 | In distribution | |
| ORG-9100A | In distribution | ||
| BR-903PA | In distribution | ||
| BR-933PA | In distribution | ||
| YP-810P | 20 | In distribution | |
| YP-845T | 20 | In distribution | |
| YP-842T | 20 | In distribution | |
| BR-906PA | In distribution | ||
| ORG-9110A | In distribution | ||
| GZ-140P | In distribution | ||
| YP-812P | 20 | In distribution | |
| YP-843T | 20 | In distribution | |
| TL-535U | 5 | In distribution | |
| YP-813P | 20 | In distribution | |
| YP-844T | 20 | In distribution | |
| ZR-920P | In distribution | ||
| ZR-920P | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Vital Sync | Covidien LP | 29 |
| LifeSync | LifeSync Corporation | 18 |
| Surveyor Patient Cable | Mortara Instrument, Inc. | 18 |
| Isansys | Isansys Lifecare, Ltd. | 15 |
| ZephyrLIFE Home | Zephyr Technology Corporation | 11 |
| Transmitters And Receivers, Physiological Signal, Radiofrequency | Nihon Kohden America, Inc. | 9 |
| InTouch Health | Intouch Health, Inc. | 7 |
| UbiqVue | LifeSignals, Inc. | 6 |
| X12+ | Mortara Instrument, Inc. | 5 |
| Welch Allyn, Inc. | Welch Allyn, Inc. | 5 |
| Ezypro ECG Recorder | Sigknow Biomedical Co., Ltd. | 3 |
| Wi-Box™ | St. Jude Medical | 3 |
Showing 12 of 211. All products under Transmitters And Receivers, Physiological Signal, Radiofrequency
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K102106 | 2010-12-17 |
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.