K-number	K964961
Device name	MODEL 405T WITH ETCO2 OPTION
Applicant	Ivy Biomedical Systems, Inc.
Product code	CCK
Device class	Class II
Decision date	May 14, 1997
Decision	Substantially Equivalent
Regulation	868.1400

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View the full FDA submission: accessdata.fda.gov

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MODEL 405T WITH ETCO2 OPTION

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