Name: Predicase
Price: 199 USD

K-number	K945689
Device name	GAME AUDIOMETERY WORD IDENTIFICATION AUDIOMETRY FOR USE WITH PRODIGIT(TM) 2000 PERSONAL DIGITAL AUDIOMETER(TM)
Applicant	Calmed Technology, Inc.
Product code	EWO
Device class	Class II
Decision date	Feb 8, 1995
Decision	Substantially Equivalent
Regulation	874.1050

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View the full FDA submission: accessdata.fda.gov

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GAME AUDIOMETERY WORD IDENTIFICATION AUDIOMETRY FOR USE WITH PRODIGIT(TM) 2000 PERSONAL DIGITAL AUDIOMETER(TM)

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