LIPISCAN IVUS IMAGING SYSTEM MODEL NIRS-MC7-70— 510(k) K093993

Substantially Equivalent

Infraredx, Inc.

FDA 510(k) clearance K093993 for LIPISCAN IVUS IMAGING SYSTEM MODEL NIRS-MC7-70, Substantially Equivalent on 2010-06-30. Applicant: Infraredx, Inc..

Clearance details

Applicant: Infraredx, Inc.
Product code: Code OGZ
Advisory panel: Cardiovascular
Date received: 2009-12-24
Decision date: 2010-06-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Burlington, MA, US

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