FDA 510(k) Applications Submitted by Tracy Yue
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K250214 |
01/24/2025 |
Acclarix AX8 Series Diagnostic Ultrasound System (Model: Acclarix AX7, Acclarix AX8, Acclarix AX75, Acclarix AX78, Acclarix AX8 Exp, Acclarix AX8 Super), Acclarix AX9 Series Diagnostic Ultrasound Szystem (Model: Acclarix AX9 Basic, Acclarix AX9, Acclarix |
Edan Instruments Inc. |
| K240320 |
02/02/2024 |
Patient Monitor (RespArray) |
Edan Instruments, Inc |
| K151978 |
07/17/2015 |
EDAN i15 Blood Gas and Chemistry Analysis System, EDAN i15 Calibrant Fluid Pack, EDAN i15 Blood Gas and Electrolyte Control, EDAN i15 Hematocrit Control |
EDAN INSTRUMENTS, INC. |
| K232694 |
09/05/2023 |
Central Monitoring System (MFM-CMS) |
Edan Instruments, Inc. |
| K232786 |
09/11/2023 |
Stimulation System (PA series, PR series, S series and Q series) |
Edan Instruments, Inc. |
| K232962 |
09/21/2023 |
Patient Monitor (iX10, iX12, iX15) |
Edan Instruments, Inc |
| K233038 |
09/25/2023 |
Vital Signs monitor, Model: iM3s, iM3As, iM3Bs, iHM3s |
Edan Instruments, Inc. |
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