K233394 is an FDA 510(k) clearance for the Gem Flow Now (GEM2770-FN). This device is classified as a System, Imaging, Pulsed Doppler, Ultrasonic (Class II - Special Controls, product code IYN).
Submitted by Synovis Micro Companies Alliance (Birmingham, US). The FDA issued a Cleared decision on January 28, 2024, 117 days after receiving the submission on October 3, 2023.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 892.1550.
| 510(k) Number | K233394 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 03, 2023 |
| Decision Date | January 28, 2024 |
| Days to Decision | 117 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | IYN - System, Imaging, Pulsed Doppler, Ultrasonic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1550 |