Cleared Traditional

Power Infuser

K172653 · ZOLL Medical Corporation · General Hospital
Jul 2018
Decision
316d
Days
Class 2
Risk

About This 510(k) Submission

K172653 is an FDA 510(k) clearance for the Power Infuser, a Pump, Infusion (Class II — Special Controls, product code FRN), submitted by ZOLL Medical Corporation (Chelsmford, US). The FDA issued a Cleared decision on July 18, 2018, 316 days after receiving the submission on September 5, 2017. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number K172653 FDA.gov
FDA Decision Cleared SESE
Date Received September 05, 2017
Decision Date July 18, 2018
Days to Decision 316 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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