Clearance Summary
DINAMAP RESEARCH MONITOR 1245 received FDA 510(k) clearance under submission number K800025, sponsored by Applied Medical Research. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1980-02-01.
- Submission: K800025
- Applicant / Sponsor: Applied Medical Research
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1130
- Decision date: 1980-02-01
Classification & Regulation
This clearance is catalogued under FDA product code DXN and 21 CFR 870.1130, within the Cardiovascular review panel as a Class II device.