Clearance Summary
ULTRASONIC QFM SYSTEM 1000 received FDA 510(k) clearance under submission number K811376, sponsored by Narco Bio-Systems. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1981-08-13.
- Submission: K811376
- Applicant / Sponsor: Narco Bio-Systems
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2100
- Decision date: 1981-08-13
Classification & Regulation
This clearance is catalogued under FDA product code DPW and 21 CFR 870.2100, within the Cardiovascular review panel as a Class II device.