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510(k) K050395

IMPEDIMED - BODY COMPOSITION ANALYSIS by Impedimed Pty , Ltd. — Product Code MNW

K050395 is an FDA 510(k) premarket notification submitted by Impedimed Pty , Ltd. for the device "IMPEDIMED - BODY COMPOSITION ANALYSIS". The FDA issued a decision of Substantially Equivalent on July 13, 2005. The device falls under product code MNW (Analyzer, Body Composition), a Class II device regulated under 21 CFR 870.2770. Impedimed Pty , Ltd. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 13, 2005
Date Received
February 16, 2005
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 Impedimed Pty , Ltd.

  • K080825 — IMPEDIMED EXTRA CELLULAR FLUID ANALYSIS, MODEL L-DEX U400 (October 3, 2008)
  • K050415 — IMPEDIMED-EXTRACELLULAR FLUID ANALYSIS (March 30, 2007)
  • K052319 — IMPEDIMED - BODY COMPOSITION ANALYZER, MODEL IMP SFB7 (April 4, 2006)

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)
  • K130777 — INBODY (November 25, 2013)
  • 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)

FDA data resources