Data / Medical devices / China / Shenzhen Viatom Technology Co., Ltd.
Shenzhen Viatom Technology Co., Ltd.: FDA-registered device maker in Shenzhen Guangdong, China, 7 510(k) clearances
Shenzhen Viatom Technology Co., Ltd. is registered with the FDA (registration 3011200896) in Shenzhen Guangdong, China. It lists 9 device types. The FDA files 7 510(k) clearances under its listings, the newest dated February 28, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3011200896
- Address
- Floor 3, Building 9, Baiwangxin Industrial Park, No.1002 Songbai Road Yangguang Community, Xili Street, Nanshan District, Shenzhen Guangdong, China, 518055
- Owner or operator
- Shenzhen Viatom Technology Co., Ltd. (10050841)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- January 11, 2016
- Registered through
- 2026
- Brand names listed
- AirBP Blood Pressure Monitor, Baby Sleep Monitor BabyO2, Baby Sleep Monitor BabyO2 S2, Baby Sleep Monitor S1, Babytone Sleep Satview (S1), Babytone Sleep Sock (S1), Babytone Sleep Sock + (S1), Blood Pressure Monitor, models BP2, BP2A and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrocardiograph | DPS | 2 | Manufacturer | accessdata.fda.gov |
| Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | MWI | 2 | Manufacturer | accessdata.fda.gov |
| Oximeter | DQA | 2 | Manufacturer | accessdata.fda.gov |
| Oximeter, Infrared, Sporting, Aviation | OCH | 2 | Manufacturer | accessdata.fda.gov |
| Oximeter, Wellness | PGJ | 2 | Manufacturer | accessdata.fda.gov |
| System, Imaging, Pulsed Doppler, Ultrasonic | IYN | 2 | Exporter to the US | accessdata.fda.gov |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | 2 | Exporter to the US | accessdata.fda.gov |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | 2 | Manufacturer | accessdata.fda.gov |
| Transducer, Ultrasonic, Diagnostic | ITX | 2 | Exporter to the US | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 28, 2025 | K242876 | Pulse Oximeter ( PO2, PO2A, PO2B) | DQA | Substantially Equivalent | Shenzhen Viatom Technology Co., Ltd. | accessdata.fda.gov |
| November 8, 2022 | K203812 | Oxyfit Pulse Oximeter | DQA | Substantially Equivalent | Shenzhen Viatom Technology Co., Ltd. | accessdata.fda.gov |
| October 13, 2022 | K211321 | Wireless Probe Type Ultrasound Scanner (Model: CProbe; Type: Type C, Type L, Type CT, Type CL) | IYN | Substantially Equivalent | Guangzhou Sonostar Technologies Co., Ltd. | accessdata.fda.gov |
| June 25, 2020 | K193348 | Blood Pressure Monitor | DXN | Substantially Equivalent | Shenzhen Viatom Technology Co., Ltd. | accessdata.fda.gov |
| December 2, 2019 | K191088 | Checkme O2 Pulse Oximeter | DQA | Substantially Equivalent | Shenzhen Viatom Technology Co., Ltd. | accessdata.fda.gov |
| August 19, 2019 | K190207 | Blood Pressure Monitor | DXN | Substantially Equivalent | Shenzhen Viatom Technology Co., Ltd. | accessdata.fda.gov |
| December 10, 2015 | K150869 | Checkme Pro Health Monitor | MWI | Substantially Equivalent | Viatom Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
- All makers of Oximeter
- All makers of Oximeter, Wellness
- All makers of System, Imaging, Pulsed Echo, Ultrasonic
- All makers of Transducer, Ultrasonic, Diagnostic
- All makers of System, Imaging, Pulsed Doppler, Ultrasonic
Updated February 28, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.