Name: Predicase
Price: 199 USD

K-number	K950853
Device name	OPTIONAL DISPLAY AND SOFTWARE FOR DRAGER VENTILATORS
Applicant	Drager, Inc.
Product code	CBK
Device class	Class II
Decision date	Nov 5, 1996
Decision	Substantially Equivalent - Subject to Tracking Reg.
Regulation	868.5895

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Source

View the full FDA submission: accessdata.fda.gov

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OPTIONAL DISPLAY AND SOFTWARE FOR DRAGER VENTILATORS

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