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Omron Healthcare, Inc.

FDA 510(k) & PMA Approved Devices — 15 products

Total Devices15
Categories3
Latest Approval2024-10-08
TypeNumberDevice NameCodeDate
510(k) DEN230076 Omron Blood Pressure Monitor with Atrial Fibrillation (AFib) Detection Feature (BP7460 (HEM-7371T1-AZ)); Omron Blood Pressure Monitor with Atrial Fibrillation (AFib) Detection Feature (BP5460 (HEM-7372T1-AZAZ)) QXY 2024-10-08 View
510(k) K202228 Omron Model BP7900 Blood Pressure Monitor + EKG DXN 2021-04-01 View
510(k) K183215 Focus TENS Therapy, Model PM710-M/-L NUH 2019-09-07 View
510(k) K190693 HEM-6410T-ZL Wrist Blood Pressure Monitor DXN 2019-04-17 View
510(k) K182579 Omron Model BP7900 Blood Pressure Monitor + EKG DXN 2019-03-14 View
510(k) K182120 Maxpower Relief NUH 2019-01-10 View
510(k) K181992 Heat Pain Pro NUH 2018-11-09 View
510(k) K182481 HEM-6410T-ZM Wrist Blood Pressure Monitor DXN 2018-11-09 View
510(k) K182166 Wrist Blood Pressure Monitor Model BP4350 DXN 2018-11-08 View
510(k) K182127 Wrist Blood Pressure Monitor Model BP6100 DXN 2018-11-02 View
510(k) K172079 Avail NUH 2017-10-19 View
510(k) K163235 HEM-9210T DXN 2017-04-20 View
510(k) K163045 Omron HEM-6400T-Z Wrist Blood Pressure Monitor DXN 2017-02-21 View
510(k) K162092 Evolv Model BP7000 Upper Arm Blood Pressure Monitor DXN 2016-11-22 View
510(k) K160115 Heat Pain Pro NUH 2016-06-03 View
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