Name: Predicase
Price: 199 USD

K-number	K953161
Device name	MAICO MA630D AUDIOMETER WITH OPTIONAL REFLEX DECAY & EUSTACHIAN TUBE FUNCTION
Applicant	Maico Hearing Instruments, Inc.
Product code	ETY
Device class	Class II
Decision date	Jul 24, 1995
Decision	Substantially Equivalent
Regulation	874.1090

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Source

View the full FDA submission: accessdata.fda.gov

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MAICO MA630D AUDIOMETER WITH OPTIONAL REFLEX DECAY & EUSTACHIAN TUBE FUNCTION

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