Clearance Summary
SONAR-AID(R) ULTRASOUND STANDOFF PAD received FDA 510(k) clearance under submission number K874943, sponsored by Geistlich-Pharma. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1988-07-25.
- Submission: K874943
- Applicant / Sponsor: Geistlich-Pharma
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1570
- Decision date: 1988-07-25
Classification & Regulation
This clearance is catalogued under FDA product code ITX and 21 CFR 892.1570, within the Radiology review panel as a Class II device.