ENVIEW (TM)— 510(k) K102179

Substantially Equivalent

Carefusion 2200

FDA 510(k) clearance K102179 for ENVIEW (TM), Substantially Equivalent on 2010-12-02. Applicant: Carefusion 2200. Device class: 2.

Clearance details

Applicant: Carefusion 2200
Product code: Code OCV
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2010-08-03
Decision date: 2010-12-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, 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.