Cadd Solis Vip Ambulatory Infusion Pump and Cadd Solis Medication Safety Software
FDA 510(k) K111275 · Smiths Medical Asd, Inc.
510(k) numberK111275
Submission
- Device name
- Cadd Solis Vip Ambulatory Infusion Pump and Cadd Solis Medication Safety Software
- Applicant
- Smiths Medical Asd, Inc.
St. Paul, MN, US - Received
- May 6, 2011
- Decision date
- February 1, 2013
- 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 Cadd Solis Vip Ambulatory Infusion Pump and Cadd Solis Medication Safety Software cleared by the FDA?
Cadd Solis Vip Ambulatory Infusion Pump and Cadd Solis Medication Safety Software (K111275) received a 510(k) decision of Substantially Equivalent on February 1, 2013, 637 days after the submission was received.
What is the product code of K111275?
The FDA product code is FRN – Pump, Infusion, a Class II (moderate risk) device regulated under 21 CFR 880.5725.