INFINIA LIGHTSPEED— 510(k) K043381

Name: FDA 510(k) clearance K043381
Creator: U.S. Food and Drug Administration
Published: 2004-12-23

Substantially Equivalent

Ge Medical Systems F.I. Haifa

FDA 510(k) clearance K043381 for INFINIA LIGHTSPEED, Substantially Equivalent on 2004-12-23. 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: 2004-12-09
Decision date: 2004-12-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tirat Hacarmel, IL

Download summary PDF View on FDA.gov ↗

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