Signature Edition Gold Infusion System, Model 7X3X

Q: What is the product code of K063288?

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

FDA 510(k) K063288 · Cardinal Health 303,Inc.

Substantially Equivalent

510(k) numberK063288

Submission

Device name: Signature Edition Gold Infusion System, Model 7X3X
Applicant: Cardinal Health 303,Inc.
San Diego, CA, US
Received: November 1, 2006
Decision date: November 28, 2006
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 Gold Infusion System, Model 7X3X cleared by the FDA?

Signature Edition Gold Infusion System, Model 7X3X (K063288) received a 510(k) decision of Substantially Equivalent on November 28, 2006, 27 days after the submission was received.

What is the product code of K063288?

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