ICG MODULE— 510(k) K010164

Substantially Equivalent

General Electric Medical Systems Information Techn

FDA 510(k) clearance K010164 for ICG MODULE, Substantially Equivalent on 2001-04-09. Applicant: General Electric Medical Systems Information Techn. Device class: 2.

Clearance details

Applicant
General Electric Medical Systems Information Techn
Product code
Code DSB
Device class
Class 2
Regulation
21 CFR 870.2770
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Milwaukee, WI, US
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