Submission Details
| 510(k) Number | K141102 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 29, 2014 |
| Decision Date | July 08, 2014 |
| Days to Decision | 70 days |
| Submission Type | Special |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
K141102 is an FDA 510(k) clearance for the HOSPIRA MEDNET MEDICATION MANAGEMENT SUITE, a Pump, Infusion (Class II — Special Controls, product code FRN), submitted by Hospira, Inc. (Lake Forest, US). The FDA issued a Cleared decision on July 8, 2014, 70 days after receiving the submission on April 29, 2014. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K141102 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 29, 2014 |
| Decision Date | July 08, 2014 |
| Days to Decision | 70 days |
| Submission Type | Special |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FRN — Pump, Infusion |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 880.5725 |