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510(k) K213730

MESI mTABLET TBI diagnostic system, MESI mTABLET TBI by Mesi, Development of Medical Devices, Ltd.; Mesi D.O.O. — Product Code JOM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 21, 2022
Date Received
November 26, 2021
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, Development of Medical Devices, Ltd.; Mesi D.O.O.

  • K223670 — MESI mTablet ECG Diagnostic System, MESI mTablet ECG (July 28, 2023)

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  • 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)