NXSTAGE DIALYSATE PREPARATION MODULE— 510(k) K060296

Name: FDA 510(k) clearance K060296
Creator: U.S. Food and Drug Administration
Published: 2006-03-31

Substantially Equivalent

Nxstage Medical, Inc.

FDA 510(k) clearance K060296 for NXSTAGE DIALYSATE PREPARATION MODULE, Substantially Equivalent on 2006-03-31. Applicant: Nxstage Medical, Inc.. Device class: 2.

Clearance details

Applicant: Nxstage Medical, Inc.
Product code: Code FKR
Device class: Class 2
Regulation: 21 CFR 876.5820
Advisory panel: Gastroenterology, Urology
Date received: 2006-02-06
Decision date: 2006-03-31
Decision: Substantially Equivalent
Clearance type: Special
Location: Lawrence, MA, US

Download summary PDF View on FDA.gov ↗

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