The following data is part of a premarket notification filed by Sims Deltec, Inc. with the FDA for Cadd-prizm Pcs Ii Model 6101 Ambulatory Infusion System.
| Device ID | K000842 |
| 510k Number | K000842 |
| Device Name: | CADD-PRIZM PCS II MODEL 6101 AMBULATORY INFUSION SYSTEM |
| Classification | Pump, Infusion |
| Applicant | SIMS DELTEC, INC. 1265 GREY FOX RD. St. Paul, MN 55112 |
| Contact | Lisa Stone |
| Correspondent | Lisa Stone SIMS DELTEC, 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 | 2000-03-15 |
| Decision Date | 2000-06-08 |