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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: Andesfit Limited ADF-B19
Classification Name: SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE
Product Code: DXN
Device Class: 2
Regulation Number: 870.1130
Medical Specialty: Cardiovascular
Registered Establishment Name: ANDESFIT LIMITED
Registered Establishment Number: 3014074923
Premarket Submission Number: K161846
Owner/Operator: ANDESFIT LIMITED
Owner/Operator Number: 10057989
Establishment Operations: Foreign Exporter; Foreign Private Label Distributor
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