The following data is part of a premarket notification filed by Smiths Medical Md, Inc. with the FDA for Cadd -solis Ambulatory Infusion Pump And Cadd -solis Medication Safety Software - Administrator.
| Device ID | K072144 |
| 510k Number | K072144 |
| Device Name: | CADD -SOLIS AMBULATORY INFUSION PUMP AND CADD -SOLIS MEDICATION SAFETY SOFTWARE - ADMINISTRATOR |
| Classification | Pump, Infusion, Pca |
| Applicant | SMITHS MEDICAL MD, INC. 1265 GREY FOX RD. Arden Hills, MN 55112 |
| Contact | Phil Neururer |
| Correspondent | Phil Neururer SMITHS MEDICAL MD, INC. 1265 GREY FOX RD. Arden Hills, MN 55112 |
| Product Code | MEA |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-08-02 |
| Decision Date | 2008-03-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10610586039232 | K072144 | 000 |
| 10610586043543 | K072144 | 000 |
| 10610586035012 | K072144 | 000 |
| 10610586035005 | K072144 | 000 |
| 10610586031861 | K072144 | 000 |
| 10610586031212 | K072144 | 000 |
| 10610586041327 | K072144 | 000 |
| 10610586031342 | K072144 | 000 |