Clearance Summary
PHONOCARDIOGRAPH received FDA 510(k) clearance under submission number K924054, sponsored by Echo Ultrasound. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1993-01-22.
- Submission: K924054
- Applicant / Sponsor: Echo Ultrasound
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class I
- Regulation citation: 21 CFR 870.2390
- Decision date: 1993-01-22
Classification & Regulation
This clearance is catalogued under FDA product code DQC and 21 CFR 870.2390, within the Cardiovascular review panel as a Class I device.