Glucopro Infusion Set, Model Gpisxxxxxxxx Series

FDA 510(k) K011120 · Nipro Diabetes Systems, Inc.

Substantially Equivalent

510(k) numberK011120

Submission

Device name
Glucopro Infusion Set, Model Gpisxxxxxxxx Series
Applicant
Nipro Diabetes Systems, Inc.
Lexington, KY, US
Received
April 12, 2001
Decision date
May 8, 2001
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
FPA – Set, Administration, Intravascular
Device class
Class II (moderate risk)
Regulation
21 CFR 880.5440
Specialty
General Hospital

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More from B.Braun Medical, Inc.

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Questions and answers

When was Glucopro Infusion Set, Model Gpisxxxxxxxx Series cleared by the FDA?

Glucopro Infusion Set, Model Gpisxxxxxxxx Series (K011120) received a 510(k) decision of Substantially Equivalent on May 8, 2001, 26 days after the submission was received.

What is the product code of K011120?

The FDA product code is FPA – Set, Administration, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 880.5440.