Parker Micropump Model 2100

Q: What is the product code of K902309?

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

FDA 510(k) K902309 · Chathamborough Research Group, Inc.

Substantially Equivalent

510(k) numberK902309

Submission

Device name: Parker Micropump Model 2100
Applicant: Chathamborough Research Group, Inc.
Pittsboro, NC, US
Received: May 23, 1990
Decision date: August 17, 1990
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)

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 Parker Micropump Model 2100 cleared by the FDA?

Parker Micropump Model 2100 (K902309) received a 510(k) decision of Substantially Equivalent on August 17, 1990, 86 days after the submission was received.

What is the product code of K902309?

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