Becton Dickinson Rate Infuser II System
FDA 510(k) K896593 · Bd Becton Dickinson Vacutainer Systems Preanalytic
510(k) numberK896593
Submission
- Device name
- Becton Dickinson Rate Infuser II System
- Applicant
- Bd Becton Dickinson Vacutainer Systems Preanalytic
Franklin Lakes, NJ, US - Received
- November 21, 1989
- Decision date
- December 27, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 Becton Dickinson Rate Infuser II System cleared by the FDA?
Becton Dickinson Rate Infuser II System (K896593) received a 510(k) decision of Substantially Equivalent on December 27, 1989, 36 days after the submission was received.
What is the product code of K896593?
The FDA product code is FRN – Pump, Infusion, a Class II (moderate risk) device regulated under 21 CFR 880.5725.