Cleared Traditional

MZ1000

K132413 · Care Fusion · General Hospital
Aug 2013
Decision
27d
Days
Class 2
Risk

About This 510(k) Submission

K132413 is an FDA 510(k) clearance for the MZ1000, a Set, Administration, Intravascular (Class II — Special Controls, product code FPA), submitted by Care Fusion (San Diego, US). The FDA issued a Cleared decision on August 29, 2013, 27 days after receiving the submission on August 2, 2013. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K132413 FDA.gov
FDA Decision Cleared SESE
Date Received August 02, 2013
Decision Date August 29, 2013
Days to Decision 27 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FPA — Set, Administration, Intravascular
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5440

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