K-number	K001369
Device name	RESPIEVENTS, VERSION 4.2
Applicant	Non-Invasive Monitoring Systems, Inc.
Product code	DQK
Device class	Class II
Decision date	Jul 26, 2000
Decision	Substantially Equivalent
Regulation	870.1425

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Source

View the full FDA submission: accessdata.fda.gov

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RESPIEVENTS, VERSION 4.2

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