Clearance Summary
IMPEDANCE RHEOGRAPH received FDA 510(k) clearance under submission number K772093, sponsored by Dynatech Research & Development 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 1977-11-18.
- Submission: K772093
- Applicant / Sponsor: Dynatech Research & Development Co.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2750
- Decision date: 1977-11-18
Classification & Regulation
This clearance is catalogued under FDA product code DQB and 21 CFR 870.2750, within the Cardiovascular review panel as a Class II device.