SEER MC— 510(k) K042782

Name: FDA 510(k) clearance K042782
Creator: U.S. Food and Drug Administration
Published: 2005-09-02

Substantially Equivalent

Ge Medical Systems Information Technologies

FDA 510(k) clearance K042782 for SEER MC, Substantially Equivalent on 2005-09-02. Applicant: Ge Medical Systems Information Technologies. Device class: 2.

Clearance details

Applicant: Ge Medical Systems Information Technologies
Product code: Code MLO
Device class: Class 2
Regulation: 21 CFR 870.2800
Advisory panel: Cardiovascular
Date received: 2004-10-06
Decision date: 2005-09-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Milwaukee, WI, US

Download summary PDF View on FDA.gov ↗

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