K213974 is an FDA 510(k) clearance for the GEM FLOW COUPLER Monitor (GEM1020M-2). This device is classified as a Flowmeter, Blood, Cardiovascular (Class II - Special Controls, product code DPW).
Submitted by Synovis Micro Companies Alliance, Inc. (Birmingham, US). The FDA issued a Cleared decision on April 20, 2022, 121 days after receiving the submission on December 20, 2021.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 870.2100.
| 510(k) Number | K213974 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 20, 2021 |
| Decision Date | April 20, 2022 |
| Days to Decision | 121 days |
| Submission Type | Special |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | DPW - Flowmeter, Blood, Cardiovascular |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2100 |