FDA 510(k) Applications Submitted by Edan Instruments, Inc
FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
K180862 |
04/02/2018 |
Acclarix LX8 Diagnostic Ultrasound System, Acclarix AX8 Diagnostic Ultrasound System |
Edan Instruments, Inc |
K173042 |
09/28/2017 |
Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express; Fetal Monitor: Models F2, F3 |
Edan Instruments, Inc |
K171900 |
06/26/2017 |
Acclarix AX4 Diagnostic Ultrasound System |
Edan Instruments, Inc |
K192879 |
09/30/2019 |
Acclarix AX8 Diagnostic Ultrasound System / Acclarix LX9 Series Diagnostic Ultrasound System |
Edan Instruments, Inc |
K210140 |
01/19/2021 |
electrocardiograph: SE-1202 |
Edan Instruments, Inc |
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