Clearance Summary
HA-2 HUMAN BODY COMPOSITION ANALYZER received FDA 510(k) clearance under submission number K860749, sponsored by Dj Medical Instrument Corp. C/O Keller & Heckman. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1986-09-02.
- Submission: K860749
- Applicant / Sponsor: Dj Medical Instrument Corp. C/O Keller & Heckman
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2770
- Decision date: 1986-09-02
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.