Clearance Summary
UST-5268P-5 TRANSDUCER received FDA 510(k) clearance under submission number K950607, sponsored by Aloka Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1995-09-15.
- Submission: K950607
- Applicant / Sponsor: Aloka Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1140
- Decision date: 1995-09-15
Classification & Regulation
This clearance is catalogued under FDA product code KRK and 21 CFR 870.1140, within the Cardiovascular review panel as a Class II device.