K111339 is an FDA 510(k) clearance for the HEMOSTASIS MANAGMENT SYSTEM PLUS (HMS-PLUS). This device is classified as a Analyzer, Heparin, Automated (Class II - Special Controls, product code JOX).
Submitted by Medtronic, Inc. (Mounds View, US). The FDA issued a Cleared decision on June 8, 2011, 27 days after receiving the submission on May 12, 2011.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.5680.
| 510(k) Number | K111339 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 12, 2011 |
| Decision Date | June 08, 2011 |
| Days to Decision | 27 days |
| Submission Type | Special |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
| Product Code | JOX — Analyzer, Heparin, Automated |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.5680 |