510(k) K111275
K111275 is an FDA 510(k) premarket notification submitted by Smiths Medical Asd, Inc. for the device "CADD SOLIS VIP AMBULATORY INFUSION PUMP AND CADD SOLIS MEDICATION SAFETY SOFTWARE". The FDA issued a decision of Substantially Equivalent on February 1, 2013. The device falls under product code FRN (Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. Smiths Medical Asd, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 1, 2013
- Date Received
- May 6, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pump, Infusion
- Device Class
- Class II
- Regulation Number
- 880.5725
- Review Panel
- HO
- Submission Type