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510(k) K202228

Omron Model BP7900 Blood Pressure Monitor + EKG by Omron Healthcare, Inc. — Product Code DXN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 1, 2021
Date Received
August 7, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Measurement, Blood-Pressure, Non-Invasive
Device Class
Class II
Regulation Number
870.1130
Review Panel
CV
Submission Type

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  • K181992 — Heat Pain Pro (November 9, 2018)
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  • K182166 — Wrist Blood Pressure Monitor Model BP4350 (November 8, 2018)
  • K182127 — Wrist Blood Pressure Monitor Model BP6100 (November 2, 2018)
  • K172079 — Avail (October 19, 2017)

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