K-number	K143438
Device name	Flowtron ACS900
Applicant	Getinge (Suzhou) Co., Ltd.
Product code	JOW
Device class	Class II
Decision date	Jun 23, 2015
Decision	Substantially Equivalent
Regulation	870.5800

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View the full FDA submission: accessdata.fda.gov

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Flowtron ACS900

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