The following data is part of a premarket notification filed by Smiths Medical Md, Inc. with the FDA for Cadd -solis Medication Safety Software: Administrator And Point-of-care.
| Device ID | K082783 |
| 510k Number | K082783 |
| Device Name: | CADD -SOLIS MEDICATION SAFETY SOFTWARE: ADMINISTRATOR AND POINT-OF-CARE |
| Classification | Accessories, Pump, Infusion |
| Applicant | SMITHS MEDICAL MD, INC. 1265 GREY FOX RD. St. Paul, MN 55112 |
| Contact | Phil Neururer |
| Correspondent | Phil Neururer SMITHS MEDICAL MD, INC. 1265 GREY FOX RD. St. Paul, MN 55112 |
| Product Code | MRZ |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-23 |
| Decision Date | 2008-12-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10610586033803 | K082783 | 000 |
| 10610586033797 | K082783 | 000 |
| 10610586033780 | K082783 | 000 |