Clearance Summary
PHYSIO-DYNE ECG/HR 3 received FDA 510(k) clearance under submission number K854847, sponsored by Physio-Dyne Industrument Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1986-06-16.
- Submission: K854847
- Applicant / Sponsor: Physio-Dyne Industrument Corp.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2300
- Decision date: 1986-06-16
Classification & Regulation
This clearance is catalogued under FDA product code DRT and 21 CFR 870.2300, within the Cardiovascular review panel as a Class II device.