Clearance Summary
DIGITAL TRANSTELEPHONIC ECG MONITORING SYSTEM received FDA 510(k) clearance under submission number K892370, sponsored by Bio-Focus, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1989-08-28.
- Submission: K892370
- Applicant / Sponsor: Bio-Focus, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2920
- Decision date: 1989-08-28
Classification & Regulation
This clearance is catalogued under FDA product code DXH and 21 CFR 870.2920, within the Cardiovascular review panel as a Class II device.