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510(k) K182579

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 14, 2019
Date Received
September 19, 2018
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

Other clearances by Omron Healthcare, Inc.

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  • K190693 — HEM-6410T-ZL Wrist Blood Pressure Monitor (April 17, 2019)
  • K182120 — Maxpower Relief (January 10, 2019)
  • K181992 — Heat Pain Pro (November 9, 2018)
  • K182481 — HEM-6410T-ZM Wrist Blood Pressure Monitor (November 9, 2018)
  • 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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