Omron Healthcare, Inc.

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

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Filters

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) (5) Analyzer, Body Composition (MNW) (2) Stimulator, Nerve, Transcutaneous, Over-The-Counter (NUH) (2) Nebulizer (Direct Patient Interface) (CAF) (1) Stimulator, Electrical, Transcutaneous, For Arthritis (NYN) (1)

Premarket Exempt

No Yes

Clear

Evolv Upper Arm Blood Pressure Monitor - 00073796270001 Catalog Number :

Device Class : 2

Duns Number: 054318779

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

3 Series Blood Pressure Monitor - 00073796271046 Catalog Number : BP710

Device Description : Blood Pressure Monitor - upper arm

Device Class :

Duns Number: 054318779

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

5 Series Blood Pressue Monitor - 00073796274245 Catalog Number : BP742N

Device Description : Upper Arm Blood Pressure Monitor

Device Class :

Duns Number: 054318779

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

7 Series Blood Pressure Monitor - 00073796276041 Catalog Number :

Device Class :

Duns Number: 054318779

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

Avail Wireless Pad - 00073796276140 Catalog Number : PMWPAD-L

Device Description : Large Pad for Avail wireless TENS device PM601

Device Class : 2

Duns Number: 054318779

Premarket Exempt : No

Product Code : NYN, NUH

Prescription Use : No

Device Count : 1

10 Series Blood Pressure Monitor - 00073796278540 Catalog Number :

Device Class :

Duns Number: 054318779

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

Omron Max Power Relief - 00073796303235 Catalog Number : PM3032CAN

Device Description : Electrotherapy Pain Relief TENS Unit

Device Class :

Duns Number: 054318779

Premarket Exempt : No

Product Code : NUH

Prescription Use : No

Device Count : 1

Fat Loss Monitor - 00073796306304 Catalog Number :

Device Class :

Duns Number: 054318779

Premarket Exempt : No

Product Code : MNW

Prescription Use : No

Device Count : 1

Fat Loss Monitor - 00073796306342 Catalog Number : HBF-306CAN

Device Description : Omron Fat Loss Monitor

Device Class :

Duns Number: 054318779

Premarket Exempt : No

Product Code : MNW

Prescription Use : No

Device Count : 1

Omron Air Filters for NE-C28 - 00073796328627 Catalog Number : C28FL

Device Description : Omron Air Filters for Nebulizer NE-C28

Device Class :

Duns Number: 054318779

Premarket Exempt : No

Product Code : CAF

Prescription Use : No

Device Count : 5

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