MYOLIGHT— 510(k) K033874

Substantially Equivalent

Ge Medical Systems F.I. Haifa

FDA 510(k) clearance K033874 for MYOLIGHT, Substantially Equivalent on 2003-12-30. Applicant: Ge Medical Systems F.I. Haifa. Device class: 2.

Clearance details

Applicant: Ge Medical Systems F.I. Haifa
Product code: Code KPS
Device class: Class 2
Regulation: 21 CFR 892.1200
Advisory panel: Radiology
Date received: 2003-12-15
Decision date: 2003-12-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tirat Hacarmel, 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.