Name: Predicase
Price: 199 USD

K-number	K051874
Device name	SEDLINE SEDATION MONITOR WITH FRONTAL PSI AND SEDTRACE EEG ELECTROSE SET
Applicant	Physiometrix, Inc.
Product code	OLW
Device class	Class II
Decision date	Sep 2, 2005
Decision	Substantially Equivalent
Regulation	882.1400

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Source

View the full FDA submission: accessdata.fda.gov

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SEDLINE SEDATION MONITOR WITH FRONTAL PSI AND SEDTRACE EEG ELECTROSE SET

Everything you need for a 510(k) submission. Nothing you don't.