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510(k) K130777

INBODY by Biospace Corporation Limited — Product Code MNW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 25, 2013
Date Received
March 21, 2013
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 Biospace Corporation Limited

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  • K123228 — INBODY 770, INBODY 570, INBODY S10, INBODY H20/INBODY H20(B) (March 8, 2013)
  • K110689 — INBODY (August 19, 2011)
  • K092786 — INBODY, MODELS: 270, R20, R20B (March 10, 2010)
  • K062603 — BIOSPACE BODY COMPOSITION ANALYZERS, MODEL INBODY 230 (February 15, 2007)
  • K052646 — BIOSPACE BODY COMPOSITION ANALYZERS, MODELS INBODY 520, 720 AND S20 (December 16, 2005)
  • K042528 — INBODY, MODEL 3.0 (January 11, 2005)

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)
  • 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)