510(k) clearances

Upper Arm Blood pressure monitor (BP7155D)

OMRON Healthcare, Inc. · Cardiovascular

K261929Substantially EquivalentSpecialDXN
Open FDA's page for this record
Third party flag
N
City
Hoffman Estates
Advisory committee description
Cardiovascular
Address 1
2895 Greenspoint Pkwy.
Address 2
Suite 100
Statement or summary
Summary
Product code
DXN
Zip code
60169
Applicant
OMRON Healthcare, Inc.
Decision date
2026-09-10
Decision code
SESE
Country code
US
Device name
Upper Arm Blood pressure monitor (BP7155D)
Advisory committee
CV
Contact
Bhoomika Joyappa
K number
K261929
State
IL
Date received
2026-06-09
Review advisory committee
CV
Postal code
60169
Decision description
Substantially Equivalent
Clearance type
Special
Harmonized identifiers (openFDA)
Device name
System, Measurement, Blood-Pressure, Non-Invasive
Medical specialty description
Cardiovascular
Regulation number
870.1130
Device class
2
Registration number
3013826848, 3027645104, 8022257, 3011420269, 3010536822, 3008573045, 3016075711, 2029275, 3010421104, 3004415095, 3013679558, 3023412068, 1218950, 3021131596, 9611045, 3009001657, 3007621003, 3001034529, 3010968402, 3003971136, 3007583504, 3006441164, 3003981912, 9617543, 3008011951, 3003832357, 3010703925, 3010838917, 3016452327, 3012134907, 3008264255, 3011651103, 3008167616, 3004101980, 3006808382, 3026567235, 3019130, 3008164770, 3027344406, 3003800159 +392 more
FEI number
3013826848, 3027645104, 3011420269, 3010536822, 1000292048, 3008573045, 3016075711, 3003081151, 3010421104, 3004415095, 3013679558, 3023412068, 1218950, 3021131596, 1000518731, 3009001657, 3007621003, 3001034529, 3010968402, 3003971136, 3007583504, 3006441164, 3003981912, 3000718682, 3008011951, 3003832357, 3003339185, 3010703925, 3010838917, 3016452327, 3012134907, 3008264255, 3011651103, 3008167616, 3004101980, 3006808382, 3026567235, 3019130, 3008164770, 3027344406 +392 more
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.