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Omron Healthcare, Inc.

FDA 510(k) & PMA Approved Devices — 14 products

Total Devices14
Categories2
Latest FDA decision2021-04-01
TypeNumberDevice NameCodeDateActions
510(k) K202228 Omron Model BP7900 Blood Pressure Monitor + EKGDXN2021-04-01 View
510(k) K183215 Focus TENS Therapy, Model PM710-M/-LNUH2019-09-07 View
510(k) K190693 HEM-6410T-ZL Wrist Blood Pressure MonitorDXN2019-04-17 View
510(k) K182579 Omron Model BP7900 Blood Pressure Monitor + EKGDXN2019-03-14 View
510(k) K182120 Maxpower ReliefNUH2019-01-10 View
510(k) K181992 Heat Pain ProNUH2018-11-09 View
510(k) K182481 HEM-6410T-ZM Wrist Blood Pressure MonitorDXN2018-11-09 View
510(k) K182166 Wrist Blood Pressure Monitor Model BP4350DXN2018-11-08 View
510(k) K182127 Wrist Blood Pressure Monitor Model BP6100DXN2018-11-02 View
510(k) K172079 AvailNUH2017-10-19 View
510(k) K163235 HEM-9210TDXN2017-04-20 View
510(k) K163045 Omron HEM-6400T-Z Wrist Blood Pressure MonitorDXN2017-02-21 View
510(k) K162092 Evolv Model BP7000 Upper Arm Blood Pressure MonitorDXN2016-11-22 View
510(k) K160115 Heat Pain ProNUH2016-06-03 View
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