The following data is part of a premarket notification filed by Medex, Inc. with the FDA for Pharmguard Toolbox, Model G6000782.
| Device ID | K042432 |
| 510k Number | K042432 |
| Device Name: | PHARMGUARD TOOLBOX, MODEL G6000782 |
| 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 | 2004-09-08 |
| Decision Date | 2005-01-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00610586032335 | K042432 | 000 |