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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: Zybs Medical Upper Arm Electronic Blood Pressure Monitor Model: U08B
Classification Name: SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE
Product Code: DXN
Device Class: 2
Regulation Number: 870.1130
Medical Specialty: Cardiovascular
Registered Establishment Name: ZYBS CONSULTING LLC DBA ZYBS MEDICAL GROUP, DBA ZYBS MEDICAL
Registered Establishment Number: 3036999955
Premarket Submission Number: K160019
Owner/Operator: Zybs Consulting llc Dba Zybs Medical, Dba Zybs Medical Devic
Owner/Operator Number: 10093047
Establishment Operations: Repackager/Relabeler
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