510(k) K140623

Device: NXSTAGE EXPRESS FLUID WARMER
Applicant: NXSTAGE MEDICAL, INC.
510(k) number: K140623
Product code: FLA
Decision: Substantially Equivalent (SESE)
Decision date: 2014-06-16
Date received: 2014-03-11
Regulation: 876.5820
Classification name: Monitor, Temperature, Dialysis
Medical specialty: Gastroenterology/Urology
Review panel: Gastroenterology/Urology
Device class: 2
Clearance type: Special
Statement or summary: Summary
Third party reviewed: No

Applicant Contact#

Contact: MARY LOU STROUMBOS
Address: 350 Merrimack St. Lawrence MA US 01843 01843

FDA Registration Numbers#

3003464075
3014856521
9616074

Source Documents#

Other 510(k) Records For Product Code FLA #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K842302	FLUID WARMER	Organon Teknika Corp.	1984-08-27
K810021	FLO-TEMP	Laminar Flow Industries	1981-01-23

Legacy Summary#

summary

FDA Review#

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