NXSTAGE EXPRESS FLUID WARMER— 510(k) K140623

Name: FDA 510(k) clearance K140623
Creator: U.S. Food and Drug Administration
Published: 2014-06-16

Substantially Equivalent

Nxstage Medical, Inc.

FDA 510(k) clearance K140623 for NXSTAGE EXPRESS FLUID WARMER, Substantially Equivalent on 2014-06-16. Applicant: Nxstage Medical, Inc.. Device class: 2.

Clearance details

Applicant: Nxstage Medical, Inc.
Product code: Code FLA
Device class: Class 2
Regulation: 21 CFR 876.5820
Advisory panel: Gastroenterology, Urology
Date received: 2014-03-11
Decision date: 2014-06-16
Decision: Substantially Equivalent
Clearance type: Special
Location: Lawrence, MA, US

Download summary PDF View on FDA.gov ↗

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