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510(k) K160956

LD-Oxi system by Ld Technology, LLC — Product Code MWI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 6, 2016
Date Received
April 5, 2016
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Device Class
Class II
Regulation Number
870.2300
Review Panel
CV
Submission Type

Other clearances by Ld Technology, LLC

  • K200287 — BP-BT Kiosk (May 15, 2020)
  • K200141 — Oxi-W System (April 27, 2020)
  • K173696 — TBL-ABI System (December 19, 2017)
  • K152216 — SudoC (September 24, 2015)
  • K143152 — TM-ABI system (July 22, 2015)
  • K140412 — ANS1 SOFTWARE (May 22, 2014)
  • K131568 — SUDO PATH (June 28, 2013)
  • K130056 — PATIENT MONITOR (April 11, 2013)
  • K113264 — ELECTRO SENSOR COMPLEX SOFTWARE (ES COMPLEX SOFTWARE) (March 2, 2012)
  • K103026 — ELECTRO SENSOR -BODY COMPOSITION (March 29, 2011)

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