K-number	K141565
Device name	GLOBE-TROTTER GT5400
Applicant	Draeger Medical Systems, Inc.
Product code	FPL
Device class	Class II
Decision date	Sep 10, 2014
Decision	Substantially Equivalent
Regulation	880.5410

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Source

View the full FDA submission: accessdata.fda.gov

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GLOBE-TROTTER GT5400

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