510(k) K091828
K091828 is an FDA 510(k) premarket notification submitted by Sheathing Technologies, Inc. for the device "SHEATHESISO ULTRASOUND TRANSDUCER COVER". The FDA issued a decision of Substantially Equivalent on September 28, 2009. The device falls under product code ITX (Transducer, Ultrasonic, Diagnostic), a Class II device regulated under 21 CFR 892.1570. Sheathing Technologies, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 28, 2009
- Date Received
- June 19, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Transducer, Ultrasonic, Diagnostic
- Device Class
- Class II
- Regulation Number
- 892.1570
- Review Panel
- RA
- Submission Type