The following data is part of a premarket notification filed by Medex, Inc. with the FDA for Medex 3000 Series Mr Syringe Infusion Pump.
| Device ID | K040899 |
| 510k Number | K040899 |
| Device Name: | MEDEX 3000 SERIES MR SYRINGE INFUSION PUMP |
| Classification | Pump, Infusion |
| Applicant | MEDEX, INC. 6250 SHIER RINGS RD. Dublin, OH 40316 |
| Contact | Barbara Law |
| Correspondent | Barbara Law MEDEX, INC. 6250 SHIER RINGS RD. Dublin, OH 40316 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-04-06 |
| Decision Date | 2004-04-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15019517130928 | K040899 | 000 |
| 10610586043246 | K040899 | 000 |
| 10610586032318 | K040899 | 000 |