CerOX— 510(k) K150268

Substantially Equivalent

Or-Nim Medical , Ltd.

FDA 510(k) clearance K150268 for CerOX, Substantially Equivalent on 2015-11-06. Applicant: Or-Nim Medical , Ltd.. Device class: 2.

Clearance details

Applicant: Or-Nim Medical , Ltd.
Product code: Code DPW
Device class: Class 2
Regulation: 21 CFR 870.2100
Advisory panel: Cardiovascular
Date received: 2015-02-04
Decision date: 2015-11-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kfar Saba, IL

Download summary PDF View on FDA.gov ↗

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