Name: Predicase
Price: 199 USD

K-number	K990522
Device name	WARATAH DIGITAL EEG AND SLEEP ACQUISITION DEVICES WITH, OR WITHOUT, PULSE OXIMETRY,CARDINAL DIGITAL EEG AND SLEEP ACQUIS
Applicant	Lamont Medical, Inc.
Product code	OLV
Device class	Class II
Decision date	May 19, 1999
Decision	Substantially Equivalent
Regulation	882.1400

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Source

View the full FDA submission: accessdata.fda.gov

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WARATAH DIGITAL EEG AND SLEEP ACQUISITION DEVICES WITH, OR WITHOUT, PULSE OXIMETRY,CARDINAL DIGITAL EEG AND SLEEP ACQUIS

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