510(k) K061153
K061153 is an FDA 510(k) premarket notification submitted by Gynesonics, Inc. for the device "GYNESONICS EC6 TRANSDUCER". The FDA issued a decision of Substantially Equivalent on October 27, 2006. The device falls under product code ITX (Transducer, Ultrasonic, Diagnostic), a Class II device regulated under 21 CFR 892.1570. Gynesonics, Inc. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 27, 2006
- Date Received
- April 26, 2006
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Transducer, Ultrasonic, Diagnostic
- Device Class
- Class II
- Regulation Number
- 892.1570
- Review Panel
- RA
- Submission Type