Automated ankle brachial pressure index measuring device— 510(k) K172655

Name: FDA 510(k) clearance K172655
Creator: U.S. Food and Drug Administration
Published: 2018-01-11

Substantially Equivalent

Mesi D.O.O.; Mesi, Development of Medical Devices, Ltd.

FDA 510(k) clearance K172655 for Automated ankle brachial pressure index measuring device, Substantially Equivalent on 2018-01-11. Applicant: Mesi D.O.O.; Mesi, Development of Medical Devices, Ltd.. Device class: 2.

Clearance details

Applicant: Mesi D.O.O.; Mesi, Development of Medical Devices, Ltd.
Product code: Code JOM
Device class: Class 2
Regulation: 21 CFR 870.2780
Advisory panel: Cardiovascular
Date received: 2017-09-05
Decision date: 2018-01-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ljubljana, SI

Download summary PDF View on FDA.gov ↗

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