Clearance Summary
IRREGULAR CURVE TRACING REVISITION & DOPPLER received FDA 510(k) clearance under submission number K853769, sponsored by Hewlett-Packard Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1985-10-31.
- Submission: K853769
- Applicant / Sponsor: Hewlett-Packard Co.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2330
- Decision date: 1985-10-31
Classification & Regulation
This clearance is catalogued under FDA product code DXK and 21 CFR 870.2330, within the Cardiovascular review panel as a Class II device.