Accufuser; Accufuser Plus

FDA 510(k) K003915 · Help Technologies

Substantially Equivalent

510(k) numberK003915

Submission

Device name
Accufuser; Accufuser Plus
Applicant
Help Technologies
Dana Point, CA, US
Received
December 19, 2000
Decision date
February 15, 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
MEB – Pump, Infusion, Elastomeric
Device class
Class II (moderate risk)
Regulation
21 CFR 880.5725
Specialty
General Hospital

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More from Advanced Infusion, Inc.

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Questions and answers

When was Accufuser; Accufuser Plus cleared by the FDA?

Accufuser; Accufuser Plus (K003915) received a 510(k) decision of Substantially Equivalent on February 15, 2001, 58 days after the submission was received.

What is the product code of K003915?

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