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 |
| K240320 |
02/02/2024 |
Patient Monitor (RespArray) |
Edan Instruments, Inc |
| K232962 |
09/21/2023 |
Patient Monitor (iX10, iX12, iX15) |
Edan Instruments, Inc |
| K210140 |
01/19/2021 |
electrocardiograph: SE-1202 |
Edan Instruments, Inc |
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