Modification to: Multirate Infusor SV )with and Without PCM), Multirate Infusor LV (with and Without PCM)
FDA 510(k) K051253 · Baxter Healthcare Corp
510(k) numberK051253
Submission
- Device name
- Modification to: Multirate Infusor SV )with and Without PCM), Multirate Infusor LV (with and Without PCM)
- Applicant
- Baxter Healthcare Corp
Mcgaw Park, IL, US - Received
- May 16, 2005
- Decision date
- July 15, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MEA – Pump, Infusion, Pca
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5725
- Specialty
- General Hospital
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Questions and answers
When was Modification to: Multirate Infusor SV )with and Without PCM), Multirate Infusor LV (with and Without PCM) cleared by the FDA?
Modification to: Multirate Infusor SV )with and Without PCM), Multirate Infusor LV (with and Without PCM) (K051253) received a 510(k) decision of Substantially Equivalent on July 15, 2005, 60 days after the submission was received.
What is the product code of K051253?
The FDA product code is MEA – Pump, Infusion, Pca, a Class II (moderate risk) device regulated under 21 CFR 880.5725.