510(k) K211691
K211691 is an FDA 510(k) premarket notification submitted by Ultrast, Inc. for the device "Ultrast Gel". The FDA issued a decision of Substantially Equivalent on December 22, 2021. The device falls under product code MUI (Media, Coupling, Ultrasound), a Class II device regulated under 21 CFR 892.1570.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 22, 2021
- Date Received
- June 2, 2021
- 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