510(k) K163026
K163026 is an FDA 510(k) premarket notification submitted by Pharmaceutical Innovations, Inc. for the device "Ultra/Phonic Scanning Gel". The FDA issued a decision of Substantially Equivalent on January 9, 2018. The device falls under product code MUI (Media, Coupling, Ultrasound), a Class II device regulated under 21 CFR 892.1570. Pharmaceutical Innovations, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 9, 2018
- Date Received
- October 31, 2016
- 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