Clearance Summary
ULTRAMARK 400C/SONOACE 6000 ULTRASOUND SYSTEM received FDA 510(k) clearance under submission number K992470, sponsored by Advanced Technology Laboratories, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1999-08-23.
- Submission: K992470
- Applicant / Sponsor: Advanced Technology Laboratories, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1560
- Decision date: 1999-08-23
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.