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510(k) K193387

Arm Electronic Sphygmomanometer by Shenzhen Changkun Technology Co., Ltd. — Product Code DXN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 27, 2021
Date Received
December 6, 2019
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 Shenzhen Changkun Technology Co., Ltd.

  • K231595 — Electric Breast Pump (October 26, 2023)
  • K221798 — Finger Pulse Oximeter, Model: X1906P (May 4, 2023)
  • K193386 — Wrist Electronic Sphygmomanometer (January 27, 2021)
  • K193253 — Infrared Thermometer, Model Number CK-T1501, CK-T1502, CK-T1503 (June 17, 2020)

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