HELAX-IMCON, VERSION 1.0— 510(k) K982857

Substantially Equivalent

Helax AB

FDA 510(k) clearance K982857 for HELAX-IMCON, VERSION 1.0, Substantially Equivalent on 1998-11-04. Applicant: Helax AB. Device class: 2.

Clearance details

Applicant: Helax AB
Product code: Code KPQ
Device class: Class 2
Regulation: 21 CFR 892.5840
Advisory panel: Radiology
Date received: 1998-08-13
Decision date: 1998-11-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Uppsala, SE

Download summary PDF View on FDA.gov ↗

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