Lifecare 75 Controller
FDA 510(k) K893487 · Abbott Laboratories
510(k) numberK893487
Submission
- Device name
- Lifecare 75 Controller
- Applicant
- Abbott Laboratories
Abbott Park, IL, US - Received
- May 4, 1989
- Decision date
- July 28, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LDR – Controller, Infusion, Intravascular, Electronic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5725
- Specialty
- General Hospital
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Questions and answers
When was Lifecare 75 Controller cleared by the FDA?
Lifecare 75 Controller (K893487) received a 510(k) decision of Substantially Equivalent on July 28, 1989, 85 days after the submission was received.
What is the product code of K893487?
The FDA product code is LDR – Controller, Infusion, Intravascular, Electronic, a Class II (moderate risk) device regulated under 21 CFR 880.5725.