VISI MOBILE MONITORING SYSTEM
FDA 510(k) clearance K122036 · decided 2012-08-15
Clearance details
- K-number
- K122036
- Device name
- VISI MOBILE MONITORING SYSTEM
- Applicant
- Sotera Wireless, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2012-07-11
- Decision date
- 2012-08-15
- Days to decision
- 35 days
- Clearance type
- Traditional
- Product code
- MWI
- Device class
- 2
- Regulation number
- 870.2300
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- San Diego, CA, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| ViSi Mobile Monitor, Catalog No. 92-10010 The ViSi Mobile Monitoring System is intended fo recall (Z-1817-2013) | Sotera Wireless, Inc. | 2013-07-29 |
| ViSi Mobile Chest Sensor (3 lead-wire ECG, AAMI), Catalog No. 93-10014 The ViSi Mobile Mon recall (Z-1818-2013) | Sotera Wireless, Inc. | 2013-07-29 |