FDA 510(k), K112478, VISI MOBILE MONITORING SYSTEM

FDA 510(k), K112478, VISI MOBILE MONITORING SYSTEM

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510(K) Number: K112478
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: 08/29/2011
Decision Date: 03/22/2012
Regulation Medical Specialty: Cardiovascular
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