Abbott XL3M Infusion Pump
FDA 510(k) K952799 · Abbott Laboratories
510(k) numberK952799
Submission
- Device name
- Abbott XL3M Infusion Pump
- Applicant
- Abbott Laboratories
Abbott Park, IL, US - Received
- June 19, 1995
- Decision date
- January 18, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 XL3M Infusion Pump cleared by the FDA?
Abbott XL3M Infusion Pump (K952799) received a 510(k) decision of Substantially Equivalent on January 18, 1996, 213 days after the submission was received.
What is the product code of K952799?
The FDA product code is FRN – Pump, Infusion, a Class II (moderate risk) device regulated under 21 CFR 880.5725.