Replacement Pump Head Door Assembly, P1, Model BX10468, Replacement Pump Head Door Assembly, P2, Model BX10469
FDA 510(k) K032789 · American I.V. Products, Inc.
510(k) numberK032789
Submission
- Device name
- Replacement Pump Head Door Assembly, P1, Model BX10468, Replacement Pump Head Door Assembly, P2, Model BX10469
- Applicant
- American I.V. Products, Inc.
Hanover, MD, US - Received
- September 8, 2003
- Decision date
- October 9, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 Replacement Pump Head Door Assembly, P1, Model BX10468, Replacement Pump Head Door Assembly, P2, Model BX10469 cleared by the FDA?
Replacement Pump Head Door Assembly, P1, Model BX10468, Replacement Pump Head Door Assembly, P2, Model BX10469 (K032789) received a 510(k) decision of Substantially Equivalent on October 9, 2003, 31 days after the submission was received.
What is the product code of K032789?
The FDA product code is FRN – Pump, Infusion, a Class II (moderate risk) device regulated under 21 CFR 880.5725.