OMRON Healthcare, Inc.

FDA 510(k) & PMA Approved Devices — 63 products

Total Devices63

Categories0

Latest FDA decision

Type	Number	Device Name	Code	Date	Actions
510(k)	K261929	Upper Arm Blood pressure monitor (BP7155D)	DXN	2026-09-10	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)	K182481	HEM-6410T-ZM Wrist Blood Pressure Monitor	DXN	2018-11-09	View
510(k)	K181992	Heat Pain Pro	NUH	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
510(k)	K131749	HEM-6221	DXN	2013-10-07	View
510(k)	K131742	HEM-6131	DXN	2013-07-24	View
510(k)	K123498	BP652N (HEM-6300-Z)	DXN	2013-03-21	View
510(k)	K121932	HEM-7200-Z (BP742)	DXN	2012-08-29	View
510(k)	K120516	LONG LIFE PADTM	GXY	2012-05-17	View