ALARIS SYSTEM WITH MMS, MODEL 8XXX

Pump, Infusion

CARDINAL HEALTH 303, INC.

The following data is part of a premarket notification filed by Cardinal Health 303, Inc. with the FDA for Alaris System With Mms, Model 8xxx.

Pre-market Notification Details

Device IDK072105
510k NumberK072105
Device Name:ALARIS SYSTEM WITH MMS, MODEL 8XXX
ClassificationPump, Infusion
Applicant CARDINAL HEALTH 303, INC. 10221 WATERIDGE CIR. San Diego,  CA  92121
ContactStacy L Lewis
CorrespondentStacy L Lewis
CARDINAL HEALTH 303, INC. 10221 WATERIDGE CIR. San Diego,  CA  92121
Product CodeFRN  
CFR Regulation Number880.5725 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-07-31
Decision Date2007-12-28
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10885403960109 K072105 000
10885403515316 K072105 000
10885403515231 K072105 000
10885403515323 K072105 000
10885403830013 K072105 000
10885403801532 K072105 000
10885403810039 K072105 000
10885403811036 K072105 000
10885403812026 K072105 000
10885403801549 K072105 000
10885403810046 K072105 000
10885403811043 K072105 000
10885403812033 K072105 000
10885403830020 K072105 000
10885403896101 K072105 000
10885403897504 K072105 000
10885403810015 K072105 000

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