Clearance Summary
ULTRASCOPE received FDA 510(k) clearance under submission number K780200, sponsored by L&M Ultrascope Life Monitoring Sys.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1978-03-02.
- Submission: K780200
- Applicant / Sponsor: L&M Ultrascope Life Monitoring Sys.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1540
- Decision date: 1978-03-02
Classification & Regulation
This clearance is catalogued under FDA product code JAF and 21 CFR 892.1540, within the Radiology review panel as a Class II device.