| 2026-08-06 |
K251508 |
Telemetry Monitor (iT30, iT50) |
MHX |
— |
— |
| 2026-07-02 |
K252463 |
SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E) |
DPS |
Class II |
Cardiovascular |
| 2026-02-09 |
K251591 |
Holter ECG and ABP system (HolterABP) |
DQK |
Class II |
Cardiovascular |
| 2025-12-23 |
K251268 |
Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP) |
IYN |
Class II |
Radiology |
| 2025-08-27 |
K241882 |
Fetal & Maternal Monitor (F15A, F15A Air) |
HGM |
Class II |
Obstetrics/Gynecology |
| 2025-07-29 |
K250179 |
Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15) |
MHX |
— |
— |
| 2025-02-20 |
K250214 |
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 AX9 Exp, Acclarix AX9 Super, Acclarix AX85, Acclarix AX88) |
IYN |
Class II |
Radiology |
| 2024-06-28 |
K240320 |
Patient Monitor (RespArray) |
MHX |
— |
— |
| 2024-05-16 |
K232786 |
Stimulation System (PA series, PR series, S series and Q series) |
IPF |
Class II |
Physical Medicine |
| 2024-04-19 |
K232962 |
Patient Monitor (iX10, iX12, iX15) |
MHX |
— |
— |
| 2024-03-08 |
K233038 |
Vital Signs monitor, Model: iM3s, iM3As, iM3Bs, iHM3s |
MWI |
— |
— |
| 2024-02-05 |
K232694 |
Central Monitoring System (MFM-CMS) |
MHX |
— |
— |
| 2023-09-25 |
K230184 |
Holter ECG and ABP System |
DSH |
Class II |
Cardiovascular |
| 2023-07-28 |
K222902 |
Electrocardiograph: SE-1200 Pro and SE-1201 Pro |
DPS |
Class II |
Cardiovascular |
| 2022-08-11 |
K220308 |
Patient Monitor: RespArray |
MHX |
— |
— |
| 2022-04-07 |
K212278 |
Electrocardiograph |
DPS |
Class II |
Cardiovascular |
| 2021-10-01 |
K210140 |
electrocardiograph: SE-1202 |
DPS |
Class II |
Cardiovascular |
| 2021-10-01 |
K210139 |
Ambulatory Blood Pressure Monitor, Models: SA-10, SA-05, SA-06, SA-08 and SA-09 |
DXN |
Class II |
Cardiovascular |
| 2021-01-28 |
K202892 |
Vital Signs Monitor:iM3s, iM3As, iM3Bs, iHM3s |
MWI |
— |
— |
| 2021-01-25 |
K202856 |
Diagnostic Ultrasound System, Models: Acclarix AX3, Acclarix AX3 Exp, Acclarix AX3 Super, Acclarix AX25, Acclarix AX28, Acclarix AX2, Acclarix AX2 Exp, Acclarix AX2 Super, Acclarix AX15, Acclarix AX18, Acclarix LX3, Acclarix LX3 Exp, Acclarix LX3 Super, Acclarix LX25 and Acclarix LX28 |
IYN |
Class II |
Radiology |
| 2021-01-23 |
K202336 |
Patient Monitor |
MHX |
— |
— |
| 2020-05-21 |
K192879 |
Acclarix AX8 Diagnostic Ultrasound System / Acclarix LX9 Series Diagnostic Ultrasound System |
IYN |
Class II |
Radiology |
| 2020-04-02 |
K192514 |
Patient Monitor |
MHX |
— |
— |