Name: Predicase
Price: 199 USD

K-number	K053388
Device name	MODEL 840 VENTILATOR WITH PROPORTIONAL ASSIST VENTILATION PLUS SOFTWARE OPTION
Applicant	Puritan Bennett Corp.
Product code	CBK
Device class	Class II
Decision date	Apr 4, 2006
Decision	Substantially Equivalent
Regulation	868.5895

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Source

View the full FDA submission: accessdata.fda.gov

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MODEL 840 VENTILATOR WITH PROPORTIONAL ASSIST VENTILATION PLUS SOFTWARE OPTION

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