Clearance Summary
SONOGRAF EDP REAL-TIME ADAPTER received FDA 510(k) clearance under submission number K780578, sponsored by Foley, Lardner, Hollabaugh & Jacobs. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1978-05-25.
- Submission: K780578
- Applicant / Sponsor: Foley, Lardner, Hollabaugh & Jacobs
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1560
- Decision date: 1978-05-25
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.