COLONCAD API 3.1— 510(k) K083423

Substantially Equivalent

Medicsight Plc

FDA 510(k) clearance K083423 for COLONCAD API 3.1, Substantially Equivalent on 2011-05-17. Applicant: Medicsight Plc. Device class: 2.

Clearance details

Applicant: Medicsight Plc
Product code: Code NWE
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2008-11-19
Decision date: 2011-05-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: London, GB

Download summary PDF View on FDA.gov ↗

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