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FDA 510(k) Applications Submitted by Melody Huang
FDA 510(k) Number
Submission Date
Device Name
Applicant
K190186
02/01/2019
Acclarix AX4 Diagnostic Ultrasound System / Acclarix LX4 Diagnostic Ultrasound System
Edan Instruments, Inc.
K192879
09/30/2019
Acclarix AX8 Diagnostic Ultrasound System / Acclarix LX9 Series Diagnostic Ultrasound System
Edan Instruments, Inc
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