K-number	K832678
Device name	PHONATORY FUNCTION ANALYZER PS-77
Applicant	Kells Medical, Inc.
Product code	BXP
Device class	Class I
Decision date	Mar 7, 1984
Decision	Substantially Equivalent
Regulation	868.2885

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Source

View the full FDA submission: accessdata.fda.gov

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PHONATORY FUNCTION ANALYZER PS-77

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