NxStage System One— 510(k) K150472

Substantially Equivalent

Nxstage Medical, Inc.

FDA 510(k) clearance K150472 for NxStage System One, Substantially Equivalent on 2015-06-04. Applicant: Nxstage Medical, Inc.. Device class: 2.

Clearance details

Applicant: Nxstage Medical, Inc.
Product code: Code ODN
Device class: Class 2
Regulation: 21 CFR 876.5860
Advisory panel: Gastroenterology, Urology
Date received: 2015-02-23
Decision date: 2015-06-04
Decision: Substantially Equivalent
Clearance type: Special
Location: Lawrence, MA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.