SMART LABEL, PROPOFOL

Accessories, Pump, Infusion

AMERICAN I.V. PRODUCTS, INC Dba AIV, INC

The following data is part of a premarket notification filed by American I.v. Products, Inc Dba Aiv, Inc with the FDA for Smart Label, Propofol.

Pre-market Notification Details

Device IDK142333
510k NumberK142333
Device Name:SMART LABEL, PROPOFOL
ClassificationAccessories, Pump, Infusion
Applicant AMERICAN I.V. PRODUCTS, INC Dba AIV, INC 7485 SHIPLEY AVE Harmans,  MD  21077
ContactShannon Houchen
CorrespondentShannon Houchen
AMERICAN I.V. PRODUCTS, INC Dba AIV, INC 7485 SHIPLEY AVE Harmans,  MD  21077
Product CodeMRZ  
CFR Regulation Number880.5725 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-08-21
Decision Date2014-12-18
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
M745BX12812 K142333 000

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