Infusion Pump Primer
FDA 510(k) K834461 · Parker Hannifin Corp.
510(k) numberK834461
Submission
- Device name
- Infusion Pump Primer
- Applicant
- Parker Hannifin Corp.
Walker, MI, US - Received
- December 19, 1983
- Decision date
- January 30, 1984
- 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 Infusion Pump Primer cleared by the FDA?
Infusion Pump Primer (K834461) received a 510(k) decision of Substantially Equivalent on January 30, 1984, 42 days after the submission was received.
What is the product code of K834461?
The FDA product code is FRN – Pump, Infusion, a Class II (moderate risk) device regulated under 21 CFR 880.5725.