Name: Predicase
Price: 199 USD

K-number	K982249
Device name	INTERACOUSTICS MODEL AD229 DIAGNOSTIC AUDIOMETER
Applicant	Idem (Int'L Dist. of Electronics For Medicine)
Product code	EWO
Device class	Class II
Decision date	Aug 7, 1998
Decision	Substantially Equivalent
Regulation	874.1050

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Source

View the full FDA submission: accessdata.fda.gov

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INTERACOUSTICS MODEL AD229 DIAGNOSTIC AUDIOMETER

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