Unimix Conainer-Empty Container W/3 Lead Trans.Set
FDA 510(k) K932477 · Baxter Healthcare Corp
510(k) numberK932477
Submission
- Device name
- Unimix Conainer-Empty Container W/3 Lead Trans.Set
- Applicant
- Baxter Healthcare Corp
Round Lake, IL, US - Received
- May 24, 1993
- Decision date
- June 10, 1994
- 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 Unimix Conainer-Empty Container W/3 Lead Trans.Set cleared by the FDA?
Unimix Conainer-Empty Container W/3 Lead Trans.Set (K932477) received a 510(k) decision of Substantially Equivalent on June 10, 1994, 382 days after the submission was received.
What is the product code of K932477?
The FDA product code is KPE – Container, I.V., a Class II (moderate risk) device regulated under 21 CFR 880.5025.