The following data is part of a premarket notification filed by Smiths Medical Md, Inc. with the FDA for Cadd-sentry Pro Medication Safety Software.
| Device ID | K062592 |
| 510k Number | K062592 |
| Device Name: | CADD-SENTRY PRO MEDICATION SAFETY SOFTWARE |
| Classification | Pump, Infusion |
| Applicant | SMITHS MEDICAL MD, INC. 1265 GREY FOX RD. St. Paul, MN 55112 |
| Contact | Melanie Hess |
| Correspondent | Melanie Hess SMITHS MEDICAL MD, INC. 1265 GREY FOX RD. St. Paul, 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 | 2006-09-01 |
| Decision Date | 2006-11-29 |
| Summary: | summary |