ISOSEED— 510(k) K140849

Substantially Equivalent

Eckert & Ziegler Bebig GmbH

FDA 510(k) clearance K140849 for ISOSEED, Substantially Equivalent on 2014-07-02. Applicant: Eckert & Ziegler Bebig GmbH. Device class: 2.

Clearance details

Applicant: Eckert & Ziegler Bebig GmbH
Product code: Code KXK
Device class: Class 2
Regulation: 21 CFR 892.5730
Advisory panel: Radiology
Date received: 2014-04-03
Decision date: 2014-07-02
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Berlin, DE

Download summary PDF View on FDA.gov ↗

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