The following data is part of a premarket notification filed by Smiths Medical Asd, Inc. with the FDA for Medfusion 4000 Pump Device Specific Reports Solfware For Pharmguard Server Version 2.0.
| Device ID | K141193 |
| 510k Number | K141193 |
| Device Name: | MEDFUSION 4000 PUMP DEVICE SPECIFIC REPORTS SOLFWARE FOR PHARMGUARD SERVER VERSION 2.0 |
| Classification | Infusion Safety Management Software |
| Applicant | SMITHS MEDICAL ASD, INC. 1265 GREY FOX ROAD St. Paul, MN 55112 |
| Contact | Tom Bliss |
| Correspondent | Tom Bliss SMITHS MEDICAL ASD, INC. 1265 GREY FOX ROAD St. Paul, MN 55112 |
| Product Code | PHC |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-05-08 |
| Decision Date | 2014-07-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15019517157888 | K141193 | 000 |
| 15019517157871 | K141193 | 000 |
| 15019517088632 | K141193 | 000 |
| 15019517225471 | K141193 | 000 |