FDA 510(k) · Wellue / Viatom
K193348: Blood Pressure Monitor (Shenzhen Viatom Technology Co., Ltd.)
Shenzhen Viatom Technology Co., Ltd. received FDA 510(k) K193348 for Blood Pressure Monitor, with a decision date of Jun 25, 2020 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K193348 |
|---|---|
| Pathway | 510(k) |
| Applicant | Shenzhen Viatom Technology Co., Ltd. |
| Device name | Blood Pressure Monitor |
| Product code | DXN: System, Measurement, Blood-Pressure, Non-Invasive |
| Regulation (21 CFR) | 870.1130 |
| Device class | Class 2 |
| Date received | Dec 3, 2019 |
| Decision date | Jun 25, 2020 |
| Decision | Substantially Equivalent (SESE) |
| 510(k) type | Traditional |
Source: openFDA device 510(k) data, data through Oct 26, 2026.
Indications for use parsed from FDA documents
The Blood Pressure Monitor is indented to measure blood pressure or electrocardiogram (ECG) in home or healthcare facilities environment. The device is a blood pressure monitor intended for use in measuring blood pressure and pulse rate in adult population. The device is intended to measure, display, store and review adults’ single-channel ECG rhythms and gives some suggested symptoms such as regular beat, irregular beat, low HR and high HR. The ECG part of the device is for Rx only, and the blood pressure part is for OTC.
Extracted automatically from FDA's 510(k) summary. It can contain extraction errors and is not a verified quote. Read the wording in the FDA PDF before relying on it.
Predicates parsed from FDA documents
FDA numbers found next to the word "predicate" in the summary. The list can include reference devices; check the PDF for which device is the primary predicate.
ChatPPG interpretation
A 510(k) decision of "substantially equivalent" means FDA found the device as safe and effective as a legally marketed predicate. FDA's word for this is cleared, not approved. The clearance covers the device and indications in this submission; it does not extend to other features or versions of the same product that were not part of it. See FDA cleared vs approved.
Product code DXN is "System, Measurement, Blood-Pressure, Non-Invasive", class 2, 21 CFR 870.1130.
Our labels for filtering: claim Blood pressure, sensor Cuff. These are heuristics, not FDA fields.