FDA 510(k) · Sotera
K142827: Visi Mobile Monitoring System, Visi Mobile Chest Sensor (Sotera Wireless, Inc.)
Sotera Wireless, Inc. received FDA 510(k) K142827 for Visi Mobile Monitoring System, Visi Mobile Chest Sensor, with a decision date of Jul 20, 2015 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K142827 |
|---|---|
| Pathway | 510(k) |
| Applicant | Sotera Wireless, Inc. |
| Device name | Visi Mobile Monitoring System, Visi Mobile Chest Sensor |
| Product code | MHX: Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) |
| Regulation (21 CFR) | 870.1025 |
| Device class | Class 2 |
| Date received | Sep 30, 2014 |
| Decision date | Jul 20, 2015 |
| Decision | Substantially Equivalent (SESE) |
| 510(k) type | Abbreviated |
Source: openFDA device 510(k) data, data through Oct 26, 2026.
Indications for use parsed from FDA documents
The ViSi Mobile Monitoring System is intended for use by clinicians and medically qualified personnel for single or multi-parameter vital signs monitoring of adult patients (18 years or older). It is indicated for ECG (3 or 5 lead-wire), respiration rate, heart rate, noninvasive blood pressure (NIBP), continuous non- invasive blood pressure (cNIBP), non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, skin temperature, basic arrhythmia analysis (Ventricular Tachycardia, Ventricular Fibrillation, Asystole, Atrial Fibrillation/Atrial Flutter) and alarm in hospital-based facilities; including general medical-surgical floors, intermediate care floors, and emergency departments. Sotera Wireless, Inc. 10020 Huennekens Street San Diego, California 92121 858.427.4620
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.
Later records that cite K142827
- K180472 ViSi Mobile Monitoring System (Sotera, Jun 19, 2018, MHX)
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 MHX is "Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)", class 2, 21 CFR 870.1025.
Our labels for filtering: claim Remote / vital-sign monitoring, sensor Unknown. These are heuristics, not FDA fields.