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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: CMS8000 Patient Monitor; CMS9000 Patient Monitor; CMS7000 Patient Monitor; CMS9100 Patient Monitor; CMS9100PLUS Patient Monitor; VITAPIA7000B Patient Monitor
Classification Name: SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE
Product Code: DXN
Device Class: 2
Regulation Number: 870.1130
Medical Specialty: Cardiovascular
Registered Establishment Name: CONTEC MEDICAL SYSTEMS CO., LTD
Registered Establishment Number: 3006979678
Premarket Submission Number: K101692
Owner/Operator: CONTEC MEDICAL SYSTEMS CO., LTD
Owner/Operator Number: 10025156
Establishment Operations: Manufacturer
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