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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S Diagnostic Ultrasound System; Hepatus 7T/Hepatus 6T/Hepatus 5T/Fibrous 7/Fibrous 6/ Fibrous 5 Diagnostic Ultrasound System
Classification Name: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
Product Code: ITX
Device Class: 2
Regulation Number: 892.1570
Medical Specialty: Radiology
Registered Establishment Name: SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.
Registered Establishment Number: 3009156722
Premarket Submission Number: K200643
Owner/Operator: SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
Owner/Operator Number: 9058402
Establishment Operations: Manufacturer
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