510(k) K190591
K190591 is an FDA 510(k) premarket notification submitted by Safersonic Us, Inc. for the device "Safergel Sterile Ultrasound Gel". The FDA issued a decision of Substantially Equivalent on October 4, 2019. 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
- October 4, 2019
- Date Received
- March 7, 2019
- 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