K221911 is an FDA 510(k) clearance for the VINNO 6PRO, VINNO 6EXP, VINNO 5PRO, VINNO 5EXP, VINNO 3, VINNO 3PRO, VINNO 3EXP. This device is classified as a System, Imaging, Pulsed Doppler, Ultrasonic (Class II - Special Controls, product code IYN).
Submitted by Vinno Technology (Suzhou) Co.,Ltd (Suzhou, CN). The FDA issued a Cleared decision on December 21, 2022, 174 days after receiving the submission on June 30, 2022.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1550.
| 510(k) Number | K221911 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 30, 2022 |
| Decision Date | December 21, 2022 |
| Days to Decision | 174 days |
| Submission Type | Special |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | IYN - System, Imaging, Pulsed Doppler, Ultrasonic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1550 |