CLEARPATH 24— 510(k) K112318

Substantially Equivalent

Promedic, Inc.

FDA 510(k) clearance K112318 for CLEARPATH 24, Substantially Equivalent on 2012-06-29. Applicant: Promedic, Inc.. Device class: 2.

Clearance details

Applicant: Promedic, Inc.
Product code: Code OCX
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2011-08-11
Decision date: 2012-06-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bonita Springs, FL, 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.