PCD 737A— 510(k) K140642

Substantially Equivalent

Mego Afek AC , Ltd.

FDA 510(k) clearance K140642 for PCD 737A, Substantially Equivalent on 2014-06-10. Applicant: Mego Afek AC , Ltd.. Device class: 2.

Clearance details

Applicant: Mego Afek AC , Ltd.
Product code: Code JOW
Device class: Class 2
Regulation: 21 CFR 870.5800
Advisory panel: Cardiovascular
Date received: 2014-03-12
Decision date: 2014-06-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Afek, 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.