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510(k) K134029

BELTER BLOOD PRESSURE METER by Shenzhen Belter Health Measurement and Analysis TE — Product Code DXN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 25, 2014
Date Received
December 31, 2013
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 Belter Health Measurement and Analysis TE

  • K140681 — BELTER INFRA-RED EAR THERMOMETER (August 21, 2014)
  • K122976 — BODY FAT SCALE MODEL SF-371 (January 4, 2013)

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