The following data is part of a premarket notification filed by Sims Deltec, Inc. with the FDA for Cadd-diplomat Pc Communications System And The Cadd- Ambassador Pump Communications System.
| Device ID | K973917 |
| 510k Number | K973917 |
| Device Name: | CADD-DIPLOMAT PC COMMUNICATIONS SYSTEM AND THE CADD- AMBASSADOR PUMP COMMUNICATIONS SYSTEM |
| Classification | Pump, Infusion |
| Applicant | SIMS DELTEC, INC. 1265 GREY FOX RD. St. Paul, MN 55112 |
| Contact | Edward W Numainville |
| Correspondent | Edward W Numainville 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 | 1997-10-15 |
| Decision Date | 1998-01-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00610586019145 | K973917 | 000 |
| 10610586026751 | K973917 | 000 |
| 10610586021770 | K973917 | 000 |