Clearance Summary
DIASCOPE TRAVELLER PLUS (4053) received FDA 510(k) clearance under submission number K964593, sponsored by S & W Medico Teknik A/S. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1997-06-30.
- Submission: K964593
- Applicant / Sponsor: S & W Medico Teknik A/S
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1025
- Decision date: 1997-06-30
Classification & Regulation
This clearance is catalogued under FDA product code DSI and 21 CFR 870.1025, within the Cardiovascular review panel as a Class II device.