Volumeric Controller
FDA 510(k) K823404 · Quest Medical, Inc.
510(k) numberK823404
Submission
- Device name
- Volumeric Controller
- Applicant
- Quest Medical, Inc.
Walker, MI, US - Received
- November 15, 1982
- Decision date
- December 22, 1982
- 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 Volumeric Controller cleared by the FDA?
Volumeric Controller (K823404) received a 510(k) decision of Substantially Equivalent on December 22, 1982, 37 days after the submission was received.
What is the product code of K823404?
The FDA product code is LDR – Controller, Infusion, Intravascular, Electronic, a Class II (moderate risk) device regulated under 21 CFR 880.5725.