The following data is part of a premarket notification filed by Pharmacia Deltec, Inc. with the FDA for Model 6100 Ambulatory Infusion System.
| Device ID | K943310 |
| 510k Number | K943310 |
| Device Name: | MODEL 6100 AMBULATORY INFUSION SYSTEM |
| Classification | Pump, Infusion, Pca |
| Applicant | PHARMACIA DELTEC, INC. 1265 GREY FOX RD. St. Paul, MN 55112 |
| Contact | David H Short |
| Correspondent | David H Short PHARMACIA DELTEC, INC. 1265 GREY FOX RD. St. Paul, MN 55112 |
| Product Code | MEA |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Se Subject To Tracking Reg (ST) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-07-11 |
| Decision Date | 1995-02-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30610586034583 | K943310 | 000 |
| 10610586026669 | K943310 | 000 |
| 10610586019227 | K943310 | 000 |
| 10610586034596 | K943310 | 000 |
| 10610586019180 | K943310 | 000 |
| 10610586023040 | K943310 | 000 |
| 10610586034558 | K943310 | 000 |
| 10610586034565 | K943310 | 000 |
| 10610586034602 | K943310 | 000 |
| 10610586018909 | K943310 | 000 |