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FDA 510(k), K180472, ViSi Mobile Monitoring System
FDA 510(k), K180472, ViSi Mobile Monitoring System
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510(K) Number: K180472
Device Name: ViSi Mobile Monitoring System
Manufacturer: Sotera Wireless, Inc.
Device Classification Name: monitor, physiological, patient(with arrhythmia detection or alarms)
Regulation Number: 870.1025
Classification Product Code: MHX
Date Received: 02/22/2018
Decision Date: 06/19/2018
Regulation Medical Specialty: Cardiovascular
Device Name: ViSi Mobile Monitoring System
Manufacturer: Sotera Wireless, Inc.
Device Classification Name: monitor, physiological, patient(with arrhythmia detection or alarms)
Regulation Number: 870.1025
Classification Product Code: MHX
Date Received: 02/22/2018
Decision Date: 06/19/2018
Regulation Medical Specialty: Cardiovascular
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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