FDA 510(k), K130709, VISI MOBILE MONITORING SYSTEM
FDA 510(k), K130709, VISI MOBILE MONITORING SYSTEM
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510(K) Number: K130709
Device Name: VISI MOBILE MONITORING SYSTEM
Manufacturer: SOTERA WIRELESS, INC
Device Classification Name: monitor, physiological, patient (without arrhythmia detection or alarms)
Regulation Number: 870.2300
Classification Product Code: MWI
Date Received: 03/15/2013
Decision Date: 10/07/2013
Regulation Medical Specialty: Cardiovascular
Device Name: VISI MOBILE MONITORING SYSTEM
Manufacturer: SOTERA WIRELESS, INC
Device Classification Name: monitor, physiological, patient (without arrhythmia detection or alarms)
Regulation Number: 870.2300
Classification Product Code: MWI
Date Received: 03/15/2013
Decision Date: 10/07/2013
Regulation Medical Specialty: Cardiovascular