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510(k) K142333

SMART LABEL, PROPOFOL by American I.V. Products, Inc. Dba Aiv, Inc. — Product Code MRZ

K142333 is an FDA 510(k) premarket notification submitted by American I.V. Products, Inc. Dba Aiv, Inc. for the device "SMART LABEL, PROPOFOL". The FDA issued a decision of Substantially Equivalent on December 18, 2014. The device falls under product code MRZ (Accessories, Pump, Infusion), a Class II device regulated under 21 CFR 880.5725.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 18, 2014
Date Received
August 21, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessories, Pump, Infusion
Device Class
Class II
Regulation Number
880.5725
Review Panel
HO
Submission Type

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FDA data resources