VISI MOBILE MONITORING SYSTEM— 510(k) K112478
Substantially EquivalentSotera Wireless, Inc.
FDA 510(k) clearance K112478 for VISI MOBILE MONITORING SYSTEM, Substantially Equivalent on 2012-03-22. Applicant: Sotera Wireless, Inc.. Device class: 2.
Clearance details
- Applicant
- Sotera Wireless, Inc.
- Product code
- Code MWI
- Device class
- Class 2
- Regulation
- 21 CFR 870.2300
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Diego, CA, US
Recent devices under product code MWI
view allMore clearances from Sotera Wireless, Inc.
view allAdverse events under product code MWI
product code MWI- Death
- 16
- Malfunction
- 963
- Total
- 979
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K112478
K-number listed on FDA's recall record- 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.
- 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.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K112478.
Data sourced from openFDA. This site is unofficial and independent of the FDA.