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510(k) K140045

BODY COMPOSITION ANALYZER by Jawon Medical Co., Ltd. — Product Code MNW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 18, 2015
Date Received
January 8, 2014
Clearance Type
Traditional
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 Jawon Medical Co., Ltd.

  • K140762 — AUTOMATIC BLOOD PRESSURE MONITOR (July 2, 2015)
  • K092432 — AUTOMOATIC BLOOD PRESSURE MONITOR, MODELS: EASY X 800 AND 900 (R/L) (October 9, 2009)
  • K092431 — BODY COMPOSITION ANALYZER, MODEL: IOI 353 (October 8, 2009)
  • K072325 — BODY COMPOSITION ANALYZER, EASYBODY 202, 203, 205 (November 30, 2007)
  • K071884 — BODY COMPOSITION ANALYZER, MODELS: X-SCAN PLUS II, GAIA 359 PLUS, PLUSAVIS 333, (August 9, 2007)
  • K062462 — NON-INVASIVE BLOOD PRESSURE MONITOR, MODELS FT-500R/L AND FT-700R/L (September 29, 2006)
  • K053556 — BODY COMPOSITION ANALYZER, MODELS ZEUS 9.9 AND VENUS 5.5 (August 31, 2006)
  • K013876 — INFRARED EAR THERMOMETER, MODEL DX-707 (March 4, 2002)
  • K002722 — DIGITAL BLOOD PRESSURE MONITOR, MODELS HD-503 AND HD-505 (September 11, 2000)
  • K000675 — MANUAL DIGITAL BLOOD PRESSURE MONITOR, MODEL HD-502 (March 14, 2000)

Other clearances for product code MNW

  • K231116 — Multi-parameter detector (June 15, 2024)
  • 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)
  • K122388 — SECA MEDICAL BODY COMPOSTION ANALYZER 514, SECA MBCA 514, SECA MBCA, SECA 514 (May 2, 2013)