The following data is part of a premarket notification filed by Smiths Medical Asd, Inc. with the FDA for Cadd Solis Vip Ambulatory Infusion Pump And Cadd Solis Medication Safety Software.
| Device ID | K111275 |
| 510k Number | K111275 |
| Device Name: | CADD SOLIS VIP AMBULATORY INFUSION PUMP AND CADD SOLIS MEDICATION SAFETY SOFTWARE |
| Classification | Pump, Infusion |
| Applicant | SMITHS MEDICAL ASD, INC. 1265 GREY FOX ROAD Arden Hills, MN 55112 |
| Contact | Julie Tapper |
| Correspondent | Julie Tapper SMITHS MEDICAL ASD, INC. 1265 GREY FOX ROAD Arden Hills, MN 55112 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-05-06 |
| Decision Date | 2013-02-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15019517126884 | K111275 | 000 |
| 15019517150568 | K111275 | 000 |
| 15019517150292 | K111275 | 000 |
| 15019517150148 | K111275 | 000 |
| 15019517150001 | K111275 | 000 |
| 15019517149999 | K111275 | 000 |
| 10610586042836 | K111275 | 000 |
| 10610586042829 | K111275 | 000 |
| 10610586042591 | K111275 | 000 |
| 10610586041037 | K111275 | 000 |
| 15019517084344 | K111275 | 000 |
| 15019517126617 | K111275 | 000 |
| 15019517126600 | K111275 | 000 |
| 15019517126594 | K111275 | 000 |
| 15019517126587 | K111275 | 000 |
| 15019517096392 | K111275 | 000 |
| 15019517096385 | K111275 | 000 |
| 15019517096378 | K111275 | 000 |
| 15019517084368 | K111275 | 000 |
| 10610586042669 | K111275 | 000 |