K101271 is an FDA 510(k) clearance for the HEMOSTASIS MANAGEMENT SYSTEM PLUS (HMS PLUS ), MODEL 305 XX. 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 October 13, 2010, 160 days after receiving the submission on May 6, 2010.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.5680.
| 510(k) Number | K101271 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 06, 2010 |
| Decision Date | October 13, 2010 |
| Days to Decision | 160 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 |