Clearance Summary
BODY ANALYSIS SYSTEM (DEEMED SE 87/09/18) received FDA 510(k) clearance under submission number K851415, sponsored by Medi-Sport Testing, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1985-07-08.
- Submission: K851415
- Applicant / Sponsor: Medi-Sport Testing, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2770
- Decision date: 1985-07-08
Classification & Regulation
This clearance is catalogued under FDA product code DSB and 21 CFR 870.2770, within the Cardiovascular review panel as a Class II device.