Cleared Traditional

IPUMP PAIN MANAGEMENT SYSTEM, MODEL 2L3107, 2L3107K

K052973 · Baxter Healthcare Corp · General Hospital
Jan 2007
Decision
458d
Days
Class 2
Risk

About This 510(k) Submission

K052973 is an FDA 510(k) clearance for the IPUMP PAIN MANAGEMENT SYSTEM, MODEL 2L3107, 2L3107K, 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 January 25, 2007, 458 days after receiving the submission on October 24, 2005. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number K052973 FDA.gov
FDA Decision Cleared SESE
Date Received October 24, 2005
Decision Date January 25, 2007
Days to Decision 458 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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