NEO MAPCATH SENSOR STYLET— 510(k) K083121

Substantially Equivalent

Corpak Medsystems

FDA 510(k) clearance K083121 for NEO MAPCATH SENSOR STYLET, Substantially Equivalent on 2009-02-11. Applicant: Corpak Medsystems. Device class: 2.

Clearance details

Applicant: Corpak Medsystems
Product code: Code OMF
Device class: Class 2
Regulation: 21 CFR 880.5970
Advisory panel: General Hospital
Date received: 2008-10-22
Decision date: 2009-02-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wheeling, IL, 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.