Submission Details
| 510(k) Number | K242167 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 24, 2024 |
| Decision Date | September 19, 2024 |
| Days to Decision | 57 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
Cleared
Traditional
Sterile and Non-Sterile Ultrasonic Coupling Agent
Sep 2024
Decision
57d
Days
Class 2
Risk
About This 510(k) Submission
K242167 is an FDA 510(k) clearance for the Sterile and Non-Sterile Ultrasonic Coupling Agent, a Media, Coupling, Ultrasound (Class II — Special Controls, product code MUI), submitted by Anhui Deepblue Medical Technology Co., Ltd. (Hefei, CN). The FDA issued a Cleared decision on September 19, 2024, 57 days after receiving the submission on July 24, 2024. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1570.
Device Classification
| Product Code | MUI — Media, Coupling, Ultrasound |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 892.1570 |
Manufacturer
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