Travenol Infusion Controller 2M8052
FDA 510(k) K812510 · Travenol Laboratories, S.A.
510(k) numberK812510
Submission
- Device name
- Travenol Infusion Controller 2M8052
- Applicant
- Travenol Laboratories, S.A.
Mchenry, IL, US - Received
- September 2, 1981
- Decision date
- September 16, 1981
- 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 Travenol Infusion Controller 2M8052 cleared by the FDA?
Travenol Infusion Controller 2M8052 (K812510) received a 510(k) decision of Substantially Equivalent on September 16, 1981, 14 days after the submission was received.
What is the product code of K812510?
The FDA product code is LDR – Controller, Infusion, Intravascular, Electronic, a Class II (moderate risk) device regulated under 21 CFR 880.5725.