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510(k) K172655

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 11, 2018
Date Received
September 5, 2017
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.

  • K201046 — Automated ankle brachial pressure index measuring device, MESI mTABLET system (December 11, 2020)

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