Visi Mobile Monitoring System, Visi Mobile Chest Sensor
FDA 510(k) clearance K142827 · decided 2015-07-20
Clearance details
- K-number
- K142827
- Device name
- Visi Mobile Monitoring System, Visi Mobile Chest Sensor
- Applicant
- Sotera Wireless, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2014-09-30
- Decision date
- 2015-07-20
- Days to decision
- 293 days
- Clearance type
- Abbreviated
- Product code
- MHX
- Device class
- 2
- Regulation number
- 870.1025
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.