Name: Predicase
Price: 199 USD

K-number	K093715
Device name	EVOK 900 SERIES HEARING AID/TINNITUS MASKER OPTION DEVICE
Applicant	Magnatone Hearing Aid Corp. Dba Persona Medical
Product code	KLW
Device class	Class II
Decision date	Dec 22, 2010
Decision	Substantially Equivalent
Regulation	874.3400

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Source

View the full FDA submission: accessdata.fda.gov

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EVOK 900 SERIES HEARING AID/TINNITUS MASKER OPTION DEVICE

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