Medtronic Micromed 407C Infusion Pump, Model MMT-407C
FDA 510(k) K043600 · Medtronic Minimed
510(k) numberK043600
Submission
- Device name
- Medtronic Micromed 407C Infusion Pump, Model MMT-407C
- Applicant
- Medtronic Minimed
Northridge, CA, US - Received
- December 29, 2004
- Decision date
- March 29, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 Medtronic Micromed 407C Infusion Pump, Model MMT-407C cleared by the FDA?
Medtronic Micromed 407C Infusion Pump, Model MMT-407C (K043600) received a 510(k) decision of Substantially Equivalent on March 29, 2005, 90 days after the submission was received.
What is the product code of K043600?
The FDA product code is FRN – Pump, Infusion, a Class II (moderate risk) device regulated under 21 CFR 880.5725.