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510(k) K140067

QARDIOARM by Qardio, Inc. — Product Code DXN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 18, 2014
Date Received
January 10, 2014
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 Qardio, Inc.

  • K220106 — QardioArm 2 (June 15, 2022)
  • K201644 — QardioCore (February 28, 2021)

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