Clearance Summary
ACUSON HEARTSOUND/PULSE/RESPIRATION MODULE received FDA 510(k) clearance under submission number K900560, sponsored by Acuson 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 1990-12-03.
- Submission: K900560
- Applicant / Sponsor: Acuson Corp.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class I
- Regulation citation: 21 CFR 870.2390
- Decision date: 1990-12-03
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.