Alaris System with MMS, Model 8XXX

FDA 510(k) K072105 · Cardinal Health 303,Inc.

Substantially Equivalent

510(k) numberK072105

Submission

Device name
Alaris System with MMS, Model 8XXX
Applicant
Cardinal Health 303,Inc.
San Diego, CA, US
Received
July 31, 2007
Decision date
December 28, 2007
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
FRN – Pump, Infusion
Device class
Class II (moderate risk)
Regulation
21 CFR 880.5725
Specialty
General Hospital

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Questions and answers

When was Alaris System with MMS, Model 8XXX cleared by the FDA?

Alaris System with MMS, Model 8XXX (K072105) received a 510(k) decision of Substantially Equivalent on December 28, 2007, 150 days after the submission was received.

What is the product code of K072105?

The FDA product code is FRN – Pump, Infusion, a Class II (moderate risk) device regulated under 21 CFR 880.5725.