Omron Healthcare, Inc.

Address:2895 Greenspoint Parkway,Hoffman Est,IL,60169,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

System, Measurement, Blood-Pressure, Non-Invasive (DXN) (10) Electrocardiograph (DPS) (1) Electrocardiograph Software For Over-The-Counter Use (QDA) (1) Transmitters And Receivers, Electrocardiograph, Telephone (DXH) (1)

Premarket Exempt

No Yes

Clear

10 Series Plus Wrist Blood Pressure Monitor - 00073796266530 Catalog Number :

Device Class :

Duns Number: 054318779

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

Omron 5 Series Upper Arm Blood Pressure Monitor - 00073796267209 Catalog Number : BP7200

Device Description : Upper arm blood pressure monitor with 2 user modes and 60 readings per user.

Device Class : 2

Duns Number: 054318779

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

Omron 5 Series Connected Upper Arm Blood Pressure Monitor - 00073796267254 Catalog Number : BP7250

Device Description : Upper arm blood pressure monitor with 60 memory storage and Bluetooth connectivity.

Device Class :

Duns Number: 054318779

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

Omron 7 Series Connected Upper Arm Blood Pressure Monitor - 00073796267353 Catalog Number : BP7350

Device Description : Upper arm blood pressure monitor with Bluetooth connectivity, 2 user modes and 6 Upper arm blood pressure monitor with Bluetooth connectivity, 2 user modes and 60 readings per user.

Device Class :

Duns Number: 054318779

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

Omron 10 Series Connected Upper Arm Blood Pressure Monitor - 00073796267452 Catalog Number : BP7450

Device Description : Upper arm blood pressure monitor with Bluetooth connectivity, 2 users and 100 re Upper arm blood pressure monitor with Bluetooth connectivity, 2 users and 100 readings per user featuring TruRead.

Device Class : 2

Duns Number: 054318779

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

7 Series Plus Bluetooth Smart Blood Pressure Monitor - 00073796267612 Catalog Number : BP761N

Device Description : Upper arm blood pressure monitor with bluetooth

Device Class :

Duns Number: 054318779

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

10 Series Plus Bluetooth Smart Blood Pressure Monitor - 00073796267865 Catalog Number :

Device Class :

Duns Number: 054318779

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

Complete Blood Pressure Monitor +EKG - 00073796267902 Catalog Number : BP7900

Device Description : Blood Pressure Monitor and single channel EKG device.

Device Class : 2

Duns Number: 054318779

Premarket Exempt : No

Product Code : DPS, DXH, DXN, QDA

Prescription Use : No

Device Count : 1

Heart Guide Wrist Blood Pressure Monitor - 00073796268008 Catalog Number : BP8000-M

Device Description : Automatic Wearable Wrist Blood Pressure Monitor

Device Class : 2

Duns Number: 054318779

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

Omron Heart Guide Wrist Blood Pressure Monitor, Large - 00073796268022 Catalog Number : BP8000-L

Device Description : Wearable Wrist Blood Pressure Monitor with Fitness and Sleep Tracking

Device Class : 2

Duns Number: 054318779

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

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