Clearance Summary
SONO TRAK T.M. received FDA 510(k) clearance under submission number K790037, sponsored by Narco Air-Shields. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1979-01-26.
- Submission: K790037
- Applicant / Sponsor: Narco Air-Shields
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1560
- Decision date: 1979-01-26
Classification & Regulation
This clearance is catalogued under FDA product code IYO and 21 CFR 892.1560, within the Radiology review panel as a Class II device.