The following data is part of a premarket notification filed by Smiths Medical Md, Inc. with the FDA for Medfusion Model 4000 Syringe Infusion Pump, Pharmguard Toolbox 2 Medication Safety Software And Supported Syringes (pss).
| Device ID | K111386 |
| 510k Number | K111386 |
| Device Name: | MEDFUSION MODEL 4000 SYRINGE INFUSION PUMP, PHARMGUARD TOOLBOX 2 MEDICATION SAFETY SOFTWARE AND SUPPORTED SYRINGES (PSS) |
| Classification | Pump, Infusion |
| Applicant | SMITHS MEDICAL MD, INC. 1265 GREY FOX RD. St. Paul, MN 55112 |
| Contact | James Chapman |
| Correspondent | James Chapman SMITHS MEDICAL MD, INC. 1265 GREY FOX RD. St. Paul, MN 55112 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-05-18 |
| Decision Date | 2011-08-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15019517070996 | K111386 | 000 |
| 10610586040962 | K111386 | 000 |
| 10610586040658 | K111386 | 000 |
| 10610586040108 | K111386 | 000 |
| 10610586040092 | K111386 | 000 |
| 10610586039812 | K111386 | 000 |
| 15019517177381 | K111386 | 000 |
| 15019517177374 | K111386 | 000 |
| 15019517177367 | K111386 | 000 |
| 10610586043307 | K111386 | 000 |
| 10610586043581 | K111386 | 000 |
| 10610586043574 | K111386 | 000 |
| 10610586043567 | K111386 | 000 |
| 10610586043291 | K111386 | 000 |
| 10610586043017 | K111386 | 000 |
| 10610586041259 | K111386 | 000 |
| 10610586041242 | K111386 | 000 |
| 10610586040818 | K111386 | 000 |
| 10610586041525 | K111386 | 000 |
| 10610586041549 | K111386 | 000 |
| 15019517070750 | K111386 | 000 |
| 15019517069624 | K111386 | 000 |
| 15019517047509 | K111386 | 000 |
| 15019517047493 | K111386 | 000 |
| 15019517178067 | K111386 | 000 |
| 15019517154320 | K111386 | 000 |
| 15019517154313 | K111386 | 000 |
| 15019517154306 | K111386 | 000 |
| 15019517155167 | K111386 | 000 |
| 15019517155150 | K111386 | 000 |
| 15019517155143 | K111386 | 000 |
| 15019517151107 | K111386 | 000 |
| 10610586043611 | K111386 | 000 |
| 10610586042874 | K111386 | 000 |
| 10610586042867 | K111386 | 000 |
| 10610586042799 | K111386 | 000 |
| 10610586042423 | K111386 | 000 |
| 15019517328622 | K111386 | 000 |