COLON CAR 1.2— 510(k) K042674

Substantially Equivalent

Medicsight

FDA 510(k) clearance K042674 for COLON CAR 1.2, Substantially Equivalent on 2004-10-19. Applicant: Medicsight. Device class: 2.

Clearance details

Applicant: Medicsight
Product code: Code NWE
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2004-09-29
Decision date: 2004-10-19
Decision: Substantially Equivalent
Clearance type: Special
Location: London, GB

Download summary PDF View on FDA.gov ↗

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K042605 — COLONGRAPHY SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY2004-10-08

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