Clearance Summary
ECHOCARDIOGRAPHY received FDA 510(k) clearance under submission number K945163, sponsored by Tri W-G, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 1995-02-17.
- Submission: K945163
- Applicant / Sponsor: Tri W-G, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4960
- Decision date: 1995-02-17
Classification & Regulation
This clearance is catalogued under FDA product code LGX and 21 CFR 878.4960, within the General, Plastic Surgery review panel as a Class I device.