Cleared Traditional

MODIFICATION TO: MULTIRATE INFUSOR SV )WITH AND WITHOUT PCM), MULTIRATE INFUSOR LV (WITH AND WITHOUT PCM)

K051253 · Baxter Healthcare Corp · General Hospital
Jul 2005
Decision
60d
Days
Class 2
Risk

About This 510(k) Submission

K051253 is an FDA 510(k) clearance for the MODIFICATION TO: MULTIRATE INFUSOR SV )WITH AND WITHOUT PCM), MULTIRATE INFUSOR LV (WITH AND WITHOUT PCM), a Pump, Infusion, Pca (Class II — Special Controls, product code MEA), submitted by Baxter Healthcare Corp (Mcgaw Park, US). The FDA issued a Cleared decision on July 15, 2005, 60 days after receiving the submission on May 16, 2005. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number K051253 FDA.gov
FDA Decision Cleared SESE
Date Received May 16, 2005
Decision Date July 15, 2005
Days to Decision 60 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

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

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