Signature Edition Infusion System, Models 710X, 720X

FDA 510(k) K070268 · Cardinal Health 303,Inc.

Substantially Equivalent

510(k) numberK070268

Submission

Device name
Signature Edition Infusion System, Models 710X, 720X
Applicant
Cardinal Health 303,Inc.
San Diego, CA, US
Received
January 29, 2007
Decision date
February 23, 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 Signature Edition Infusion System, Models 710X, 720X cleared by the FDA?

Signature Edition Infusion System, Models 710X, 720X (K070268) received a 510(k) decision of Substantially Equivalent on February 23, 2007, 25 days after the submission was received.

What is the product code of K070268?

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