Baxter AS40A, AS41 Syringe Pump, Model N61WC
FDA 510(k) K012262 · National Custom Ent., Inc.
510(k) numberK012262
Submission
- Device name
- Baxter AS40A, AS41 Syringe Pump, Model N61WC
- Applicant
- National Custom Ent., Inc.
Burnsville, MN, US - Received
- July 18, 2001
- Decision date
- September 12, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- MRZ – Accessories, 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 Baxter AS40A, AS41 Syringe Pump, Model N61WC cleared by the FDA?
Baxter AS40A, AS41 Syringe Pump, Model N61WC (K012262) received a 510(k) decision of Substantially Equivalent on September 12, 2001, 56 days after the submission was received.
What is the product code of K012262?
The FDA product code is MRZ – Accessories, Pump, Infusion, a Class II (moderate risk) device regulated under 21 CFR 880.5725.