510(k) K242167
K242167 is an FDA 510(k) premarket notification submitted by Anhui Deepblue Medical Technology Co., Ltd. for the device "Sterile and Non-Sterile Ultrasonic Coupling Agent". The FDA issued a decision of Substantially Equivalent on September 19, 2024. The device falls under product code MUI (Media, Coupling, Ultrasound), a Class II device regulated under 21 CFR 892.1570. Anhui Deepblue Medical Technology Co., Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 19, 2024
- Date Received
- July 24, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Media, Coupling, Ultrasound
- Device Class
- Class II
- Regulation Number
- 892.1570
- Review Panel
- RA
- Submission Type