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FDA 510(k) & PMA Approved 器械 — 17 products

器械总数17
类别0
最新FDA决定
类型编号器械名称代码日期操作
510(k) K260276 上臂血压计型号: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 ProDXN2026-04-01 查看
510(k) K250470 耳温计(EAR-E101);耳温计(EAR-E102);耳温计(EAR-E103)FLL2025-06-23 查看
510(k) K250161 腕式血压计(AOJ-35A);腕式血压计(AOJ-35B);腕式血压计(WRS-35B);腕式血压计(AOJ-35D);腕式血压计(AOJ-35E);腕式血压计(AOJ-35F);腕式血压计(AOJ-35G);腕式血压计(WRS-35G);腕式血压计(WRS-35H);腕式血压计(WRS-35K);腕式血压计(WRS-35N);腕式血压计(WRS-35P);腕式血压计(WRS-35P)DXN2025-05-02 查看
510(k) K244000 上臂血压计 (ARM-30A+);上臂血压计 (ARM-30G2);上臂血压计 (ARM-30Q);上臂血压计 (ARM-30E+);DXN2025-04-30 查看
510(k) K250116 上臂血压计 (ARM-30H); 上臂血压计 (ARM-30J); 上臂血压计 (ARM-30K); 上臂血压计 (ARM-90B)DXN2025-04-24 查看
510(k) K232989 脉搏血氧仪(AOJ-70A);脉搏血氧仪(AOJ-70B);脉搏血氧仪(AOJ-70C);脉搏血氧仪(AOJ-70D);脉搏血氧仪(AOJ-70E)DQA2024-07-01 查看
510(k) K232128 红外体温计(AOJ-20A);红外体温计(AOJ-20Y)FLL2023-10-14 查看
510(k) K222994 上臂血压计,型号 AOJ-33A 和 AOJ-33BDXN2023-07-26 查看
510(k) K221039 红外温度计,型号 AOJ-20A, AOJ-20B, AOJ-20C, AOJ-20D, AOJ-20E, AOJ-20F, AOJ-20H, AOJ-20M, AOJ-20T, AOJ-20R 和 AOJ-20YFLL2022-12-20 查看
510(k) K222125 上臂血压计,型号 AOJ-30A, AOJ-30B, AOJ-30C, AOJ-30D, AOJ-30E, AOJ-30F 和 AOJ-30GDXN2022-12-01 查看
510(k) K221170 额温计,型号AOJ-F101、AOJ-F102、AOJ-F103、AOJ-F104 AOJ-F105、AOJ-F106、AOJ-F107FLL2022-10-07 查看
510(k) K213485 数字温度计,型号:AOJ-25A,AOJ-25B,AOJ-25C,AOJ-25D和AOJ-25EFLL2022-05-25 查看
510(k) K213503 腕式血压计,型号 AOJ-35A,AOJ-35B,AOJ-35C,AOJ-35D,AOJ-35EDXN2022-02-18 查看
510(k) K202173 脉搏血氧仪DQA2020-12-07 查看
510(k) K191180 电子血压计DXN2019-08-23 查看
510(k) K182190 胎儿多普勒KNG2018-12-19 查看
510(k) K182133 红外体温计FLL2018-11-20 查看
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