Dosi-Fuser

FDA 510(k) K040752 · Leventon, S.A.

Substantially Equivalent

510(k) numberK040752

Submission

Device name
Dosi-Fuser
Applicant
Leventon, S.A.
Esteve Sesrovires, Barcelona, ES
Received
March 24, 2004
Decision date
April 7, 2004
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA
Third-party review
Yes

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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K053149Spiro-BallBWF · Traditional 12/13/2005SE
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Questions and answers

When was Dosi-Fuser cleared by the FDA?

Dosi-Fuser (K040752) received a 510(k) decision of Substantially Equivalent on April 7, 2004, 14 days after the submission was received.

What is the product code of K040752?

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