K-number	K011320
Device name	ETG-100 OPTICAL ENCEPHALOGRAPHY SYSTEM
Applicant	Hitachi Medical Systems America, Inc.
Product code	DQA
Device class	Class II
Decision date	Aug 9, 2001
Decision	Substantially Equivalent
Regulation	870.2700

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View the full FDA submission: accessdata.fda.gov

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ETG-100 OPTICAL ENCEPHALOGRAPHY SYSTEM

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