Home / 510(k) Clearances / K112932

510(k) K112932

TRANSTEK by Zhongshan Transtek Electronics Co., Ltd. — Product Code MNW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 1, 2011
Date Received
October 3, 2011
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Body Composition
Device Class
Class II
Regulation Number
870.2770
Review Panel
GU
Submission Type

Other clearances by Zhongshan Transtek Electronics Co., Ltd.

  • K123780 — TRANSTEK BLOOD PRESSURE MONITOR (March 1, 2013)
  • 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)
  • 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)

Other clearances for product code MNW

  • K231116 — Multi-parameter detector (June 15, 2024)
  • K140045 — BODY COMPOSITION ANALYZER (February 18, 2015)
  • K141483 — BIOSPACE BODY COMPOSITION ANALYZER (September 23, 2014)
  • K133872 — ARIA WIFI SMART SCALE (June 2, 2014)
  • K140594 — BODY FAT ANALYZER AND SCALE (May 30, 2014)
  • K130856 — BIA / VITALITY ANALYZER (November 25, 2013)
  • K130777 — INBODY (November 25, 2013)
  • K130952 — PRECISION ONE LIFECARE; DETECTO; DETECTO (September 26, 2013)
  • K131394 — TRANSTEK GLASS BODY FAT ANALYZER (September 18, 2013)
  • K130311 — TRANSTEK BODY FAT ANALYZER (May 30, 2013)