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510(k) K143152

TM-ABI system by Ld Technology, LLC — Product Code JOM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 22, 2015
Date Received
November 3, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plethysmograph, Photoelectric, Pneumatic Or Hydraulic
Device Class
Class II
Regulation Number
870.2780
Review Panel
CV
Submission Type

Other clearances by Ld Technology, LLC

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  • K200141 — Oxi-W System (April 27, 2020)
  • K173696 — TBL-ABI System (December 19, 2017)
  • K160956 — LD-Oxi system (July 6, 2016)
  • K152216 — SudoC (September 24, 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)

Other clearances for product code JOM

  • K220527 — PADnet Xpress (October 20, 2022)
  • K213730 — MESI mTABLET TBI diagnostic system, MESI mTABLET TBI (April 21, 2022)
  • K200567 — ASI Plethysmogrpah Analyzer (February 26, 2021)
  • K201046 — Automated ankle brachial pressure index measuring device, MESI mTABLET system (December 11, 2020)
  • K191266 — VitalScan ANS (January 15, 2020)
  • K172655 — Automated ankle brachial pressure index measuring device (January 11, 2018)
  • K173696 — TBL-ABI System (December 19, 2017)
  • K143094 — QuantaFlo (March 5, 2015)
  • K123921 — BODYTRONIC 200 (April 26, 2013)
  • K121108 — DOPPLEX ABILITY (January 3, 2013)