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510(k) K201046

Automated ankle brachial pressure index measuring device, MESI mTABLET system by Mesi D.O.O.; Mesi, Development of Medical Devices, Ltd. — Product Code JOM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 11, 2020
Date Received
April 21, 2020
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 Mesi D.O.O.; Mesi, Development of Medical Devices, Ltd.

  • K172655 — Automated ankle brachial pressure index measuring device (January 11, 2018)

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)
  • K191266 — VitalScan ANS (January 15, 2020)
  • K172655 — Automated ankle brachial pressure index measuring device (January 11, 2018)
  • K173696 — TBL-ABI System (December 19, 2017)
  • K143152 — TM-ABI system (July 22, 2015)
  • K143094 — QuantaFlo (March 5, 2015)
  • K123921 — BODYTRONIC 200 (April 26, 2013)
  • K121108 — DOPPLEX ABILITY (January 3, 2013)