Modification to Medrad Continuum MR Infusion System
FDA 510(k) K061128 · Medrad, Inc.
510(k) numberK061128
Submission
- Device name
- Modification to Medrad Continuum MR Infusion System
- Applicant
- Medrad, Inc.
Indianola, PA, US - Received
- April 24, 2006
- Decision date
- May 22, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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 Modification to Medrad Continuum MR Infusion System cleared by the FDA?
Modification to Medrad Continuum MR Infusion System (K061128) received a 510(k) decision of Substantially Equivalent on May 22, 2006, 28 days after the submission was received.
What is the product code of K061128?
The FDA product code is FRN – Pump, Infusion, a Class II (moderate risk) device regulated under 21 CFR 880.5725.