FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ViSi Mobile Monitoring System
K Number: K180472
·
Decision Jun 19, 2018
Classifications
1
FEI Numbers
121
Registration Numbers
121
Same Product Code
424
Applicant Total
9
Review Days
117
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Basic Information
- Device Name
- ViSi Mobile Monitoring System
- K Number
- K180472
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1025
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sotera Wireless, Inc.
- Date Received
- February 22, 2018
- Decision Date
- June 19, 2018
- Product Code
- MHX
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | FDA class 2 | Cardiovascular |
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Other Clearances by Sotera Wireless, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K152341 | ViSi Mobile Monitoring System | Dec 14, 2015 | Substantially Equivalent |
| K142827 | Visi Mobile Monitoring System, Visi Mobile Chest Sensor | Jul 20, 2015 | Substantially Equivalent |
| K150361 | ViSi Mobile Monitoring System | Apr 30, 2015 | Substantially Equivalent |
| K143751 | Visi Mobile Monitoring System | Jan 23, 2015 | Substantially Equivalent |
| K133586 | VISI MOBILE MONITIORING SYSTEM | Dec 18, 2013 | Substantially Equivalent |
| K130709 | VISI MOBILE MONITORING SYSTEM | Oct 7, 2013 | Substantially Equivalent |
| K122036 | VISI MOBILE MONITORING SYSTEM | Aug 15, 2012 | Substantially Equivalent |
| K112478 | VISI MOBILE MONITORING SYSTEM | Mar 22, 2012 | Substantially Equivalent |