Pressurized Infusion Pump

FDA 510(k) K122294 · Mui Scientific

Substantially Equivalent

510(k) numberK122294

Submission

Device name
Pressurized Infusion Pump
Applicant
Mui Scientific
Mississauga, CA
Received
July 31, 2012
Decision date
November 1, 2012
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
FFX – System, Gastrointestinal Motility (Electrical)
Device class
Class II (moderate risk)
Regulation
21 CFR 876.1725
Specialty
Gastroenterology, Urology

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Questions and answers

When was Pressurized Infusion Pump cleared by the FDA?

Pressurized Infusion Pump (K122294) received a 510(k) decision of Substantially Equivalent on November 1, 2012, 93 days after the submission was received.

What is the product code of K122294?

The FDA product code is FFX – System, Gastrointestinal Motility (Electrical), a Class II (moderate risk) device regulated under 21 CFR 876.1725.