| 2026-04-01 |
K260276 |
Arm Blood Pressure Monitor Models: ARM-30C+; ARM-30M+; ARM-HA101+; ARM-3060; XS Pro; ARM-30G1; ARM-30H; Visomat double comfort; Visomat comfort 20/40 BT; ARM-3080; ARM-3081; ARM-3082; ARM-3103; ARM-3200; ARM-115; ARM-111; ARM-3102; ARM-3100; ARM-3101; SBM 15; ARM-30W; ARM-30J; ARM-30F-XL; ARM-3024-XL; ARM-3025-XL; ARM-3062-XL; 9S Pro |
DXN |
Class II |
Cardiovascular |
| 2025-06-23 |
K250470 |
Ear Thermometer (EAR-E101); Ear Thermometer (EAR-E102); Ear Thermometer (EAR-E103) |
FLL |
Class II |
General Hospital |
| 2025-05-02 |
K250161 |
Wrist Blood Pressure Monitor (AOJ-35A); Wrist Blood Pressure Monitor (AOJ-35B); Wrist Blood Pressure Monitor (WRS-35B); Wrist Blood Pressure Monitor (AOJ-35D); Wrist Blood Pressure Monitor (AOJ-35E); Wrist Blood Pressure Monitor (AOJ-35F); Wrist Blood Pressure Monitor (AOJ-35G); Wrist Blood Pressure Monitor (WRS-35G); Wrist Blood Pressure Monitor (WRS-35H); Wrist Blood Pressure Monitor (WRS-35K); Wrist Blood Pressure Monitor (WRS-35N); Wrist Blood Pressure Monitor (WRS-35P); Wrist Bloo |
DXN |
Class II |
Cardiovascular |
| 2025-04-30 |
K244000 |
Arm Blood Pressure Monitor (ARM-30A+);Arm Blood Pressure Monitor (ARM-30G2);Arm Blood Pressure Monitor (ARM-30Q);Arm Blood Pressure Monitor (ARM-30E+); |
DXN |
Class II |
Cardiovascular |
| 2025-04-24 |
K250116 |
Arm Blood Pressure Monitor (ARM-30H); Arm Blood Pressure Monitor (ARM-30J); Arm Blood Pressure Monitor (ARM-30K); Arm Blood Pressure Monitor (ARM-90B) |
DXN |
Class II |
Cardiovascular |
| 2024-07-01 |
K232989 |
Pulse Oximeter (AOJ-70A); Pulse Oximeter (AOJ-70B); Pulse Oximeter (AOJ-70C); Pulse Oximeter (AOJ-70D); Pulse Oximeter (AOJ-70E) |
DQA |
— |
— |
| 2023-10-14 |
K232128 |
Infrared Thermometer (AOJ-20A); Infrared Thermometer (AOJ-20Y) |
FLL |
Class II |
General Hospital |
| 2023-07-26 |
K222994 |
Arm Blood Pressure Monitor, models AOJ-33A and AOJ-33B |
DXN |
Class II |
Cardiovascular |
| 2022-12-20 |
K221039 |
Infrared Thermometer, models AOJ-20A, AOJ-20B, AOJ-20C, AOJ-20D, AOJ-20E, AOJ-20F, AOJ-20H, AOJ-20M, AOJ-20T, AOJ-20R and AOJ-20Y |
FLL |
Class II |
General Hospital |
| 2022-12-01 |
K222125 |
Arm Blood Pressure Monitor, models AOJ-30A, AOJ-30B, AOJ-30C, AOJ-30D, AOJ-30E, AOJ-30F and AOJ-30G |
DXN |
Class II |
Cardiovascular |
| 2022-10-07 |
K221170 |
Forehead Thermometer, models AOJ-F101, AOJ-F102, AOJ-F103, AOJ-F104 AOJ-F105, AOJ-F106, AOJ-F107 |
FLL |
Class II |
General Hospital |
| 2022-05-25 |
K213485 |
Digital Thermometer, Models: AOJ-25A, AOJ-25B, AOJ-25C, AOJ-25D and AOJ-25E |
FLL |
Class II |
General Hospital |
| 2022-02-18 |
K213503 |
Wrist Blood Pressure Monitor, models AOJ-35A, AOJ-35B, AOJ-35C, AOJ-35D, AOJ-35E |
DXN |
Class II |
Cardiovascular |
| 2020-12-07 |
K202173 |
Pulse Oximeter |
DQA |
— |
— |