Sotera Wireless, Inc.
FDA Regulatory Profile
Sotera Wireless, Inc. appears in FDA public data with 2 recalls, 9 510(k) clearances, 3 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1818-2013, Class II) was initiated on May 23, 2013. Its most recent 510(k) clearance was granted on June 19, 2018.
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 9
- Inspections
- 3
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1818-2013 | Class II | ViSi Mobile Chest Sensor (3 lead-wire ECG, AAMI), Catalog No. 93-10014 The ViSi Mobile Monitoring | May 23, 2013 |
| Z-1817-2013 | Class II | ViSi Mobile Monitor, Catalog No. 92-10010 The ViSi Mobile Monitoring System is intended for use b | May 23, 2013 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K180472 | ViSi Mobile Monitoring System | June 19, 2018 |
| K152341 | ViSi Mobile Monitoring System | December 14, 2015 |
| K142827 | Visi Mobile Monitoring System, Visi Mobile Chest Sensor | July 20, 2015 |
| K150361 | ViSi Mobile Monitoring System | April 30, 2015 |
| K143751 | Visi Mobile Monitoring System | January 23, 2015 |
| K133586 | VISI MOBILE MONITIORING SYSTEM | December 18, 2013 |
| K130709 | VISI MOBILE MONITORING SYSTEM | October 7, 2013 |
| K122036 | VISI MOBILE MONITORING SYSTEM | August 15, 2012 |
| K112478 | VISI MOBILE MONITORING SYSTEM | March 22, 2012 |