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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: Stasis Monitoring System
Classification Name: MONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS)
Product Code: MWI
Device Class: 2
Regulation Number: 870.2300
Medical Specialty: Cardiovascular
Registered Establishment Name: Johari Digital Healthcare Ltd.
Registered Establishment Number: 8040537
Premarket Submission Number: K183634
Owner/Operator: Johari Digital Healthcare Ltd.
Owner/Operator Number: 10023876
Establishment Operations: Contract Manufacturer
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