K221999 is an FDA 510(k) clearance for the Ultrasound Transmission Gels. This device is classified as a Media, Coupling, Ultrasound (Class II - Special Controls, product code MUI).
Submitted by Hony Medical Co., Ltd. (Taishan, CN). The FDA issued a Cleared decision on August 30, 2022, 54 days after receiving the submission on July 7, 2022.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1570.
| 510(k) Number | K221999 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 07, 2022 |
| Decision Date | August 30, 2022 |
| Days to Decision | 54 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | MUI - Media, Coupling, Ultrasound |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1570 |