FDA 510(k) · Sotera
K112478: VISI MOBILE MONITORING SYSTEM (Sotera Wireless, Inc.)
Sotera Wireless, Inc. received FDA 510(k) K112478 for VISI MOBILE MONITORING SYSTEM, with a decision date of Mar 22, 2012 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K112478 |
|---|---|
| Pathway | 510(k) |
| Applicant | Sotera Wireless, Inc. |
| Device name | VISI MOBILE MONITORING SYSTEM |
| Product code | MWI: Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) |
| Regulation (21 CFR) | 870.2300 |
| Device class | Class 2 |
| Date received | Aug 29, 2011 |
| Decision date | Mar 22, 2012 |
| 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 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. It is indicated for ECG (3 or 5 leadwire), respiration rate (RESP), heart rate (HR), non-invasive blood pressure (NIBP), non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO 2 ), pulse rate (PR), and skin temperature (TEMP) in hospital-based facilities; inceluding general medical-surgical floors, intermediate care floors, and emergency departments.
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 MWI is "Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)", class 2, 21 CFR 870.2300.
Our labels for filtering: claim Remote / vital-sign monitoring, sensor Unknown. These are heuristics, not FDA fields.