K141193 is an FDA 510(k) clearance for the MEDFUSION 4000 PUMP DEVICE SPECIFIC REPORTS SOLFWARE FOR PHARMGUARD SERVER VERSION 2.0. This device is classified as a Infusion Safety Management Software (Class II - Special Controls, product code PHC).
Submitted by Smiths Medical Asd, Inc. (St. Paul, US). The FDA issued a Cleared decision on July 25, 2014, 78 days after receiving the submission on May 8, 2014.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725. Infusion Safety Management Software Is A Prescription Device Intended For Use With Infusion Pumps And May Include One Or More Of The Following Capabilities: Prepopulation Of Infusion Programming Parameters, Data Retrieval And Analysis For Tracking And Trending, Drug Infusion Error Reduction Algorithms, And Alarm Transmission..
| 510(k) Number | K141193 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 08, 2014 |
| Decision Date | July 25, 2014 |
| Days to Decision | 78 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | PHC — Infusion Safety Management Software |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5725 |
| Definition | Infusion Safety Management Software Is A Prescription Device Intended For Use With Infusion Pumps And May Include One Or More Of The Following Capabilities: Prepopulation Of Infusion Programming Parameters, Data Retrieval And Analysis For Tracking And Trending, Drug Infusion Error Reduction Algorithms, And Alarm Transmission. |