The following data is part of a premarket notification filed by Medex, Inc. with the FDA for Medex 3000 Series Syringe Infusion Pump.
| Device ID | K982640 |
| 510k Number | K982640 |
| Device Name: | MEDEX 3000 SERIES SYRINGE INFUSION PUMP |
| Classification | Pump, Infusion |
| Applicant | MEDEX, INC. 3637 LACON RD. Hilliard, OH 43026 |
| Contact | Cathy Chenetski |
| Correspondent | Cathy Chenetski MEDEX, INC. 3637 LACON RD. Hilliard, OH 43026 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Se Subject To Tracking Reg (ST) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-07-29 |
| Decision Date | 1999-04-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10610586031816 | K982640 | 000 |