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510(k) K221764

InBody Blood pressure monitor, Model BPBIO480KV by Inbody Co., Ltd. — Product Code DXN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 7, 2022
Date Received
June 17, 2022
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 Inbody Co., Ltd.

  • K231174 — BPBIO750 (August 2, 2023)
  • K200560 — InBody (January 6, 2021)
  • K200442 — InBody (December 4, 2020)

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