Clearance Summary
3050 DIASCOPE NT PATIENT MONITOR received FDA 510(k) clearance under submission number K942196, 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 1995-06-28.
- Submission: K942196
- 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: 1995-06-28
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.