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510(k) K123780

TRANSTEK BLOOD PRESSURE MONITOR by Zhongshan Transtek Electronics Co., Ltd. — Product Code DXN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 1, 2013
Date Received
December 10, 2012
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

Other clearances by Zhongshan Transtek Electronics Co., Ltd.

  • K123781 — TRANSTEK GLASS BODY FAT ANALYZER (January 9, 2013)
  • K123669 — TRANSTEK WRIST BLOOD PRESSURE MONITOR (December 21, 2012)
  • K122482 — TRANSTEK WRIST BLOOD PRESSURE MONITOR (October 22, 2012)
  • K121971 — WITHINGS, SMART BODY SCALE (September 27, 2012)
  • K120058 — TRANSTEK BLOOD PRESSURE MONITOR (January 31, 2012)
  • K112932 — TRANSTEK (November 1, 2011)
  • K101681 — TRANSTEK BLOOD PRESSURE MONITOR MODEL TMB-986, TMB-987, TMB-995 (May 27, 2011)
  • K102191 — TRANSTEK GLASS BODY ANALYZER; TRANSTEK GLASS BODY ANALYZER; TRANSTEK GLASS BODY (May 2, 2011)

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