Volumetric Infusion Controller— 510(k) K153760

Name: FDA 510(k) clearance K153760
Creator: U.S. Food and Drug Administration
Published: 2016-10-03

Substantially Equivalent

DEKA Research & Development

FDA 510(k) clearance K153760 for Volumetric Infusion Controller, Substantially Equivalent on 2016-10-03. Applicant: DEKA Research & Development. Device class: 2.

Clearance details

Applicant: DEKA Research & Development
Product code: Code LDR
Device class: Class 2
Regulation: 21 CFR 880.5725
Advisory panel: General Hospital
Date received: 2015-12-30
Decision date: 2016-10-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Manchester, NH, US

Download summary PDF View on FDA.gov ↗

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