510(k) K142827
K142827 is an FDA 510(k) premarket notification submitted by Sotera Wireless, Inc. for the device "Visi Mobile Monitoring System, Visi Mobile Chest Sensor". The FDA issued a decision of Substantially Equivalent on July 20, 2015. The device falls under product code MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)), a Class II device regulated under 21 CFR 870.1025. Sotera Wireless, Inc. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 20, 2015
- Date Received
- September 30, 2014
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
- Device Class
- Class II
- Regulation Number
- 870.1025
- Review Panel
- CV
- Submission Type