Prizma— 510(k) K173589

Substantially Equivalent

G-Medical Innovations , Ltd.

FDA 510(k) clearance K173589 for Prizma, Substantially Equivalent on 2018-11-30. Applicant: G-Medical Innovations , Ltd.. Device class: 2.

Clearance details

Applicant: G-Medical Innovations , Ltd.
Product code: Code DXH
Device class: Class 2
Regulation: 21 CFR 870.2920
Advisory panel: Cardiovascular
Date received: 2017-11-20
Decision date: 2018-11-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rehovot, IL

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.