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510(k) K131064

BIOSPACE by Biospace Corporation Limited — Product Code DXN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 4, 2013
Date Received
April 16, 2013
Clearance Type
Traditional
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 Biospace Corporation Limited

  • K141483 — BIOSPACE BODY COMPOSITION ANALYZER (September 23, 2014)
  • K130777 — INBODY (November 25, 2013)
  • 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)

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