Cleared Traditional

K080297 - MEDRAD INTEGO PET INFUSION SYSTEM
(FDA 510(k) Clearance)

K080297 · Medrad, Inc. · Radiology

Jun 2008

Decision

134d

Days

Class 2

Risk

K080297 is an FDA 510(k) clearance for the MEDRAD INTEGO PET INFUSION SYSTEM, a Pump, Infusion (Class II — Special Controls, product code FRN), submitted by Medrad, Inc. (Indianola, US). The FDA issued a Cleared decision on June 17, 2008, 134 days after receiving the submission on February 4, 2008. This device falls under the Radiology review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number	K080297 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 04, 2008
Decision Date	June 17, 2008
Days to Decision	134 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF