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510(k) K190693

HEM-6410T-ZL Wrist Blood Pressure Monitor by Omron Healthcare, Inc. — Product Code DXN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 17, 2019
Date Received
March 18, 2019
Clearance Type
Special
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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  • 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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