Cleared Traditional

COLLEAGUE GUARDIAN CONFIGURATION TOOL; COLLEAGUE DL2 EVENT HISTORY DOWNLOAD SOFTWARE APPLICATION

K070125 · Baxter Healthcare Corp · General Hospital
Apr 2007
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K070125 is an FDA 510(k) clearance for the COLLEAGUE GUARDIAN CONFIGURATION TOOL; COLLEAGUE DL2 EVENT HISTORY DOWNLOAD SOFTWARE APPLICATION, a Pump, Infusion (Class II — Special Controls, product code FRN), submitted by Baxter Healthcare Corp (Mcgaw Park, US). The FDA issued a Cleared decision on April 16, 2007, 90 days after receiving the submission on January 16, 2007. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number K070125 FDA.gov
FDA Decision Cleared SESE
Date Received January 16, 2007
Decision Date April 16, 2007
Days to Decision 90 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FRN — Pump, Infusion
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5725

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