Sotera Wireless, Inc.
Sotera Wireless, Inc. holds FDA 510(k) medical device clearances, first cleared 2012, most recent 2018, with 2 FDA device recalls on record.
Top product codes for Sotera Wireless, Inc.
FDA recalls by Sotera Wireless, Inc.
- Z-1818-2013 — 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-parameter vital signs monitoring of adult patients.
- Z-1817-2013 — 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 adult patients.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Sotera Wireless, Inc.
- K180472 — ViSi Mobile Monitoring System
- K152341 — ViSi Mobile Monitoring System
- K142827 — Visi Mobile Monitoring System, Visi Mobile Chest Sensor
- K150361 — ViSi Mobile Monitoring System
- K143751 — Visi Mobile Monitoring System
- K133586 — VISI MOBILE MONITIORING SYSTEM
- K130709 — VISI MOBILE MONITORING SYSTEM
- K122036 — VISI MOBILE MONITORING SYSTEM
- K112478 — VISI MOBILE MONITORING SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.