Omron Healthcare, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
68
Inspections
3
Compliance Actions
0

Known Names

omron healthcare, omron healthcare co

Recent 510(k) Clearances

K-NumberDeviceDate
DEN230076Omron Blood Pressure Monitor with Atrial Fibrillation (AFib) Detection Feature (BP7460 (HEM-7371T1-AOctober 8, 2024
K202228Omron Model BP7900 Blood Pressure Monitor + EKGApril 1, 2021
K183215Focus TENS Therapy, Model PM710-M/-LSeptember 7, 2019
K190693HEM-6410T-ZL Wrist Blood Pressure MonitorApril 17, 2019
K182579Omron Model BP7900 Blood Pressure Monitor + EKGMarch 14, 2019
K182120Maxpower ReliefJanuary 10, 2019
K182481HEM-6410T-ZM Wrist Blood Pressure MonitorNovember 9, 2018
K181992Heat Pain ProNovember 9, 2018
K182166Wrist Blood Pressure Monitor Model BP4350November 8, 2018
K182127Wrist Blood Pressure Monitor Model BP6100November 2, 2018
K172079AvailOctober 19, 2017
K163235HEM-9210TApril 20, 2017
K163045Omron HEM-6400T-Z Wrist Blood Pressure MonitorFebruary 21, 2017
K162092Evolv Model BP7000 Upper Arm Blood Pressure MonitorNovember 22, 2016
K160115Heat Pain ProJune 3, 2016
K141978MAXPOWER RELIEFDecember 3, 2014
K142917BP652N (HEM-6300-Z)December 1, 2014
K141140COMP A-I-RSeptember 30, 2014
K133383HEM-7320March 4, 2014
K133379HEM-7311January 16, 2014