510(k) K112478 ยท MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
VISI MOBILE MONITORING SYSTEM
| Applicant | Sotera Wireless, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Mar 22, 2012 |
| Received | Aug 29, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K112478
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 29, 2013 | Sotera Wireless, Inc. ViSi Mobile Monitor, Catalog No. 92-10010
The ViSi Mobile Monitoring System is intended for use by clinicians and medically qualified personnel for single or multi-parameter vital signs monitoring of Terminated |
MWI | None listed |
| Jul 29, 2013 | Sotera Wireless, Inc. ViSi Mobile Chest Sensor (3 lead-wire ECG, AAMI), Catalog No. 93-10014
The ViSi Mobile Monitoring System is intended for use by clinicians and medically qualified personnel for single or multi-parame Terminated |
MWI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.