Clearance Summary
MODEL 100 SPECTRAVIEW received FDA 510(k) clearance under submission number K800655, sponsored by Edwards Laboratories. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1980-04-16.
- Submission: K800655
- Applicant / Sponsor: Edwards Laboratories
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class I
- Regulation citation: 21 CFR 870.2390
- Decision date: 1980-04-16
Classification & Regulation
This clearance is catalogued under FDA product code DQC and 21 CFR 870.2390, within the Cardiovascular review panel as a Class I device.