Eva TPN Container
FDA 510(k) K041415 · B.Braun Medical, Inc.
510(k) numberK041415
Submission
- Device name
- Eva TPN Container
- Applicant
- B.Braun Medical, Inc.
Allentown, PA, US - Received
- May 27, 2004
- Decision date
- August 4, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KPE – Container, I.V.
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5025
- Specialty
- General Hospital
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Questions and answers
When was Eva TPN Container cleared by the FDA?
Eva TPN Container (K041415) received a 510(k) decision of Substantially Equivalent on August 4, 2004, 69 days after the submission was received.
What is the product code of K041415?
The FDA product code is KPE – Container, I.V., a Class II (moderate risk) device regulated under 21 CFR 880.5025.