BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Omron Healthcare, Inc.

    Reg #: 1450057 · FEI: 1450057 · Expires 2026
    View on FDA
    Products
    17
    Proprietary Names
    198
    Establishment Types
    1
    Classifications
    17

    Registration Details

    Registration Name
    Omron Healthcare, Inc.
    Registration Number
    1450057
    FEI Number
    1450057
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    2895 Greenspoint Parkway
    City
    Hoffman Est
    State
    IL
    ZIP
    60169
    Country
    US

    Regulatory Submissions

    510(k) Number
    K182127

    Owner / Operator

    Firm Name
    Omron Healthcare, Inc.
    Operator Number
    10023760
    Address
    2895 Greenspoint Parkway, Suite 100
    City
    Hoffman Estates
    State
    IL
    Postal Code
    60169
    Country
    US
    Correspondent
    Terri Ingalls

    Products

    Device Name Product Code
    System, Measurement, Blood-Pressure, Non-Invasive DXN
    Analyzer, Body Composition MNW
    Scale, Stand-On, Patient FRI
    Nebulizer (Direct Patient Interface) CAF
    Stimulator, Nerve, Transcutaneous, Over-The-Counter NUH
    Analyzer, Body Composition, Exempt PUH
    Meter, Peak Flow, Spirometry BZH
    Blood Pressure Cuff DXQ
    Nebulizer, Medicinal, Non-Ventilatory (Atomizer) CCQ
    Electrode, Cutaneous GXY
    Continuous Measurement Thermometer FLL
    Mask, Oxygen BYG
    Electrocardiograph DPS
    Oscillometric-Based, Over-The-Counter, Atrial Fibrillation Notification Feature QXY
    Stimulator, Electrical, Transcutaneous, For Arthritis NYN
    Transmitters And Receivers, Electrocardiograph, Telephone DXH
    Electrocardiograph Software For Over-The-Counter Use QDA

    Proprietary Names

    BP6100 (BP6100C) RC212 BCM-500 (HBF-222T-Z) HBF-516B HBF-514C HBF-510W HN-290T SC-150 HBP-1300 BP653 BP654 BP652N C900 C30AC C28FL C911 C910 C30FL C915 NE-C30 BP629N 6021RELN2 HEM-9210T HEM-RXL31 HEM-RXL31-B (Extra Large cuff – 17” to 20”) BP9310T (HEM-7149T2-Z) PM710-L PMKBAND-L PMKNPAD PM710-M PMKBAND-M TC220(HEM-6111-TG) C803AC NE-C803 C803AT C803NEB RE-C800KD BP6000 H-CL22 H-CL22CAN BP710N BP710CANN HEM-7311 BP742N BP765CAN-CD6 BP742CANN CD-CS9 BP765 CD-WR17 HEM-741CRELN4 BP710NVA HEM-9200T HEM-ADPTW5 BP765CAN BP7100 (BP7100C) BP7200 (HEM-7150-Z) BP5450 (HEM-7343T-Z) BP5100 (BP5100C) BP7100CAN (HEM-7121-CA) BP7250 (BP7250C) BP5350 (HEM-7341T-Z) BP7250CAN (HEM-7150T-CA) BP7110VA BP9300T (HEM-7145T2-Z) BP5150 (HEM-7142T2-ZAZ) BP7255 (HEM-716CT2-Z) BP7150 (HEM-7142T2-Z) BP5000 (HEM-716CT2-Z) BCM-750 BP7000 HEM-7600T HEM-7600T-CD6 PF9940 A055ZZ C801AT C801NEB NE-C801 HEM-6410T-ZM BP8000-M HBF-306CAN HBF-306CN HBF-400CAN HBF-400 Advanced Positioning Sensor (APS) 0148 0104MAJ 0104 11-200 HEM-18 0116 H-003DS HEM-705CPN 0146Gray HEM-432CN2 PM3031 PM3031CAN PM3030 BP8000-L (HEM-6411T-ZL HEM-6410T-ZL 9911 9912 BP6350 BP4350 (BP4350C) PMLLPADCAN-L PMLLPAD-L PMLLPADCAN PMLLPAD ET720 (MC-720-Z) PM3032CAN PM3032 PM3029 PM3032CANV 9920 9921 U22-1 U22-3 U22-4 U22-5 U22-2 U100-4 NE-U100 U100-5 NE-U22V U100-2 U100-3 HCG-801 BP7260CAN BP7360 BP5465 BP5360 BP7365CAN-CD6 BP7365CAN BP7465 BP5260 BP7260 BP7460 BP5460 PM311B PM800 PM400 PM800CAN PMGELCAN PM400V H-CR17CAN H-003DCAN H-CR24 H-003D BP761 HEM-7320 BP760N BP785N BP761CANN BP786CANN 7400RELN CFX-WR17 BP761N BP786N BP761NC-CD4 BP769CAN-CD6 BP769CAN BP7350 (HEM7340T-Z) BP7350CAN (HEM-7343T-CA) BP7450 (HEM-7342T-Z) BP5250 (BP5250C) BP7450CAN (HEM-7342T-CA) HEM-FL31-B (HEM-FL31-BZ) BP7350-CD4 BP7455CAN-CD6 (HEM-7342T1-ACACD6) BP7455CAN BP5255 (HEM-716BT2-ZAZ) PM3032B PM500 PM500V HEM-RML31-B (HEM-RML31-BZ) BP7900 (HEM-7530T-Z) HEM-CS24-B (HEM-CS24-BZ) BP652 RC211 BP629 BP652CAN BP792IT BP791IT BP785SC-CD6 PMWPAD-M PM601 PMWPAD-L K202228 HEM-907-PBAT HEM-ADPT907 HEM-TUBE-130XL HEM-907-CR19 HEM-907XL HEM-907-CX19 HEM-907-CS19 HEM-907-CL19 PM311 PMGEL H-RML30

    Establishment Types

    Repack or Relabel Medical Device