Clearance Summary
MAXI-SCOPE OR ULTRA-SCOPE received FDA 510(k) clearance under submission number K912128, sponsored by Seiichi Mfg., Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1991-06-28.
- Submission: K912128
- Applicant / Sponsor: Seiichi Mfg., Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class I
- Regulation citation: 21 CFR 870.1875
- Decision date: 1991-06-28
Classification & Regulation
This clearance is catalogued under FDA product code LDE and 21 CFR 870.1875, within the Cardiovascular review panel as a Class I device.