Cleared Traditional

POWER INFUSER, MODEL M100B-3A

K090736 · ZOLL Medical Corporation · General Hospital
May 2009
Decision
62d
Days
Class 2
Risk

About This 510(k) Submission

K090736 is an FDA 510(k) clearance for the POWER INFUSER, MODEL M100B-3A, a Pump, Infusion (Class II — Special Controls, product code FRN), submitted by ZOLL Medical Corporation (Chelmsford, US). The FDA issued a Cleared decision on May 20, 2009, 62 days after receiving the submission on March 19, 2009. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number K090736 FDA.gov
FDA Decision Cleared SESE
Date Received March 19, 2009
Decision Date May 20, 2009
Days to Decision 62 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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