Abbott Plum A+ Infusion Pump, Model 12391
FDA 510(k) K024084 · Abbott Laboratories
510(k) numberK024084
Submission
- Device name
- Abbott Plum A+ Infusion Pump, Model 12391
- Applicant
- Abbott Laboratories
Abbott Park, IL, US - Received
- December 11, 2002
- Decision date
- December 31, 2002
- 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 Abbott Plum A+ Infusion Pump, Model 12391 cleared by the FDA?
Abbott Plum A+ Infusion Pump, Model 12391 (K024084) received a 510(k) decision of Substantially Equivalent on December 31, 2002, 20 days after the submission was received.
What is the product code of K024084?
The FDA product code is FRN – Pump, Infusion, a Class II (moderate risk) device regulated under 21 CFR 880.5725.