510(k) K874943
K874943 is an FDA 510(k) premarket notification submitted by Geistlich-Pharma for the device "SONAR-AID(R) ULTRASOUND STANDOFF PAD". The FDA issued a decision of Substantially Equivalent on July 25, 1988. The device falls under product code ITX (Transducer, Ultrasonic, Diagnostic), a Class II device regulated under 21 CFR 892.1570. Geistlich-Pharma has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 25, 1988
- Date Received
- December 2, 1987
- 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